The Future of Dose Escalation Management

Dose escalation studies have been used as a cornerstone in medical research to determine the most effective dose of a drug. They are usually part of early-stage, phase I clinical trials. But like so many things in our world, the COVID-19 pandemic changed how researchers approach dose escalation management. The immediate demand for a healthy, effective vaccine showcased the need for evolving best practices and spurred researchers to adopt new technologies.

These advances have spread beyond the COVID-19 vaccines and will likely reverberate throughout the field. So to best prepare you for the future of dose escalation management, we break down these changes and the new technologies below.

How Does Dose Escalation Work?

In phase I trials, dose escalation works by finding the most effective dose of a drug; that which prevents patients from being exposed to harmful or sub-therapeutic doses of the drug.

This is a fine line to walk.

As researchers seek to avoid harm, patients are often put on lower doses that are often sub-therapeutic. The dose amount is then increased, to better identify effective doses while minimizing any harmful effects to patients. This process requires diligent management and careful consideration of all the factors involved.

Why Is Dose Escalation Important?

If the dose is sub-therapeutic, precious time and resources are misused, and the patient isn’t given effective treatment as the dose isn’t high enough to be beneficial. On the other hand, if the amount is too high, the patients may be subjected to unnecessary risk, discomfort, and unpleasant side effects.  

Dose escalation seeks to find the effective dose by slowly escalating the doses in different patient groups. However, this requires the expertise and ability to manage and analyze the data of different patients within different groups by researchers while allowing these researchers to communicate effectively and quickly.

That’s a lot to manage! Luckily, this is where the Cloud Concinnity Platform comes in.

The Importance of Technology in Dose Escalation Management

The implementation of dose escalation in phase I clinical trials requires the close monitoring of each patient’s dose and response to these doses, along with various other factors. The necessary data to track quickly adds up. So how can technology help your team manage these factors?

Providing Patient Data at Your Fingertips

Cloud Concinnity offers a solution to these problems through an easy-to-use, cloud-based software that allows an oversight committee, such as the DMC, to see what’s happening with individual patients and their dosing. This clarity of information and detail of data is invaluable when determining the correct dosing for a patient and ensuring that a study’s resources are utilized as effectively as possible.  

It also allows committees and teams to make better decisions about whether or not the study should proceed. If a statistically significant number of patients aren’t responding to treatments or, worse, are reacting negatively, this will be readily apparent. This can save time, resources, and money in ending or reworking ineffective trials early.

Reducing Administrative Burden

Moreover, technologies like Cloud Concinnity reduce the administrative and operational complexity of dose escalation trials by allowing teams to keep track of patient data and communicate quickly and effectively. And, since this is all cloud-based, it’s available for any researcher to access while also providing a central point of access.

Increases Communication

These trials often require more meetings and communication between researchers, as the nuances in the data brought about by dose escalation spur debate or discussion between researchers. Luckily, we’ve created the ability for them to meet asynchronously with the Cloud Concinnity Platform, which saves valuable time and increases the power of the team to communicate effectively.

Standardizes and Automates Processes

Many of the changes brought about by the COVID-19 pandemic aren’t going anywhere any time soon. And while the need for the most efficient, safe, and effective trials utilizing dose escalation management was prevalent before the pandemic, they are even more critical now. Researchers are using dose escalation management techniques in various fields.

This increased focus on dose escalation management means that teams will need smarter process management software to help them navigate these studies designed to find the correct dose for a drug that can potentially save millions of lives. And the best way to manage dose escalation trials is with software like Cloud Concinnity, which provides the cloud-based flexibility and ease of communication that will help your team succeed.  

While other platforms may offer communication or documentation, Cloud Concinnity provides the security and capabilities to meet the compliance requirements of a clinical study. If you have any questions or would like to see a free demo of our software, please get in touch with us. We are here to help.

7 Ways Data Monitoring Committees Can Improve Clinical Trial Trust

Sponsors of clinical trials are under pressure to maintain patient safety and data quality, but the process is time-consuming and challenging to manage. This is where more intelligent clinical trial oversight software comes in handy. The correct clinical trial oversight software can automate many of the tasks associated with clinical trial oversight, improving sponsor trust. This blog post will discuss seven ways smarter clinical trial oversight software can enhance trust between sponsors and investigators.

Improve Communication between Sponsors and Investigators

All trust is built on effective two-way communication. By providing a central repository for clinical data and communication, clinical trial oversight software can help ensure that everyone involved is on the same page by automating email alerts and reminders. In doing so, clinical trial oversight software can help reduce the risk of missed deadlines and communication breakdowns.

Improve Clinical Trial Data Quality 

To effectively build sponsor trust, there needs to be confidence in the data collected during the trial. More innovative clinical trial oversight software can improve data quality by automating data collection and analysis. This can help ensure that collected data is accurate and complete while reducing the risk of human error in data entry and analysis.

Provide Real-Time Data Access

Another way that clinical trial oversight software can help foster sponsor trust is by providing transparent access to real-time data. This means that sponsors can view what is happening in the trial at any given time and can make decisions accordingly. This level of transparency can help to improve communication between all parties involved in the trial and help to ensure that everyone is on the same page.

Provide Data Analysis Flexibility 

With the right clinical trial oversight tool, sponsors can choose the level of detail they want to see in the data and tailor the reports to their specific needs. This customization level can help make sure that sponsors are getting the information they need when they need it. It also enables sponsors to designate access tiers based on the needs of the supporting team.

Streamline Operations

Clinical trial oversight software can automate many of the tasks associated with clinical trial management, freeing up time for sponsors to focus on other aspects of their job. This automation can help reduce the time required to complete a clinical trial and empower the sponsor to bring the clinical drug to market sooner. 

Sponsors are trusting that the sites conducting their trials are following the proper procedures to ensure patient safety and data quality. But with so many moving parts in a clinical trial, it's hard for sponsors to know what's really going on at each site. Clinical trial oversight software can help streamline these operations while providing transparency into the current stage of each clinical trial

Improve Patient Safety By Improving Data Accuracy 

It’s not just sponsors that can benefit from clinical trial oversight software; this software can also improve patient safety. Inaccurate data is one of the leading causes of patient safety issues. By offering a higher degree of data accuracy, clinical trial administrators and sponsors can feel more confident that the data they are gathering is accurate and up to date, empowering these individuals with the information they need to make swift, data-backed decisions for the trial can improve the patient experience.

Increase Data Security

The more secure the clinical trial, the more trust can be built with clinical trial sponsors. This can be done by using clinical trial oversight software that is HIPAA compliant and has been tested for security vulnerabilities. Another way to increase data security is by encrypting all data collected during the clinical trial. This will ensure that only authorized personnel can access the data and that it remains tamper-proof. 

Clinical Trial Oversight software can also help reduce the risk of fraudulent activities. Fraudulent activities can occur at any stage of a clinical trial. However, by using clinical trial oversight software, sponsors can reduce the risk of fraud by increasing transparency and visibility into all aspects of the trial. This software can also help to identify potential red flags that may indicate fraudulent activities and improve the security (and integrity) of the trial. 

Build Sponsor Trust With The Right Clinical Trial Oversight Software

The cost of a clinical trial oversight software pales compared to the rest of the study costs, especially relative to the benefit they can provide. Consider using clinical trial oversight software if you’re looking for a smarter way to manage your clinical trials. Clinical trial oversight software (like the Cloud Concinnity Platform) can help you build sponsor trust by automating many of the tasks associated with clinical trial management, improving data quality, and reducing the time required to complete clinical trials. 

Contact us today to learn more about how our clinical trial oversight software can help improve your sponsor's trust.

5 Considerations for a Successful Pediatric Trial

Pediatric clinical trials are essential for developing new and innovative treatments for children. However, they can be more challenging to conduct compared to standard trials as they require more oversight. There are a few key things to keep in mind when planning and conducting a pediatric trial to guarantee a positive trial experience. This blog post will outline five tips for a successful pediatric trial.

What Makes Pediatric Trials More Complex?

Pediatric trials are more complex than adult trials for a variety of reasons.

Smaller Patient Pool 

Children make up only 22% of the US population, and they generally have less severe illnesses. These considerations reduce the number of available participants in a pediatric study.

Data Collection in Pediatric Trials

Compared to trials with adult participants, who may only collect data by having the participant complete it, pediatric patients may not be able to complete the questionnaires or submit the data. This can easily lead to the data being captured in different ways, sometimes by different parents, a guardian, or healthcare professional.

Collecting Informed Consent from Children

Collecting informed consent for children can be more difficult, as children are not old enough to legally consent to a study. They might be able to provide consent through assent, but a parent’s consent is almost always necessary and appropriate. Acquiring these different types of consent will take time, as well as caring, compassionate conversations with both the patients and their parents.

5 Tips for A Successful Pediatric Trial

Allocate Enough Budget for Patient Recruitment & Trial Technology Support

Due to the complexities of a pediatric trial, it’s crucial to allocate enough funds to cover both patient recruitment and the technology that will be used to support the trial. Not only is the population of potential patients for pediatric trials smaller, but there can also be higher dropout rates as parents or patients find the study too demanding. It may be necessary to begin with a larger pool at the beginning of the study, which may require more investment than a standard trial recruitment effort.

You also want an appropriate budget for your trial technology support. Issues arising from technology that is either unknown to participants, or error-prone, can lead to delays and frustration in both participants and their parents - and these issues can easily lead to patients dropping out of the study. It’s important to invest accordingly in technology support to decrease the likelihood of dropouts.

Centralize Your Data Collection

As we mentioned above, the data collection in a pediatric study will likely be more diverse than in an adult study. Therefore, it’s important to collect and centralize the data gathered from various sources so that it can be analyzed effectively with the results from the rest of the study. Failure to do so could result in inaccurate results and conclusions from the study.

Utilize Child-friendly Protocols. 

As all of the participants in the study will be children, it’s imperative to have protocols that are best suited for them. These can manifest in different ways but could be as simple as having sessions that are no more than a couple hours long, or having breaks during the sessions. Along with the other tips listed above, these types of child friendly protocols will help decrease dropout rates.

Work With Caregivers and Parents to Eliminate Friction Points.

Raising children is already a difficult and stressful activity for most caregivers. And if a study adds additional stress to a family’s life, it can increase the likelihood that a patient will not complete the study.

To help reduce stress, it’s imperative that there are open lines of communication between trial staff and caregivers/parents. Do your best to identify and eliminate potential friction points before they become a problem for your study.

Be Aware of Your Timeline - Eliminate Unnecessary Meetings and Ensure Asynchronous Alignment to Avoid Costly Delays.

Timelines are implemented to help ensure the successful completion of your study. Adhering to them will increase the probability that your study comes in at or under budget. And revenue considerations aside, failure to complete your study on time could delay getting the medicine to those who need it the most. 

It’s important to streamline your communications to avoid unnecessary meetings to prevent these delays. By leveraging asynchronous alignment, you can be sure that everyone’s time is utilized effectively and efficiently - keeping your study on budget and on track.

One note of caution, while there are plenty of asynchronous tools on the market (email, messaging, document management apps, etc.), many lack the security, integration, and compliance-required tracking/reporting capabilities needed to meet the requirements of the clinical study. To ensure compliance, it’s important to select an asynchronous toolset that meets the traceability, auditability, and reportability required of a successful pediatric trial. 

Pro-Tip: Our asynchronous communication tools are a key feature of the Cloud Concinnity Platform. Through Cloud Concinnity, your team can comment and respond to critical questions, data notes, and action items in a secure, cloud-based environment – eliminating redundancies and helping to streamline communications. Learn more and schedule your Cloud Concinnity demo today.

By following these tips, you can increase the chances of a successful pediatric clinical trial. If you have any questions or concerns, please contact us. We are here to help. We are happy to give you a free demo of our cloud-based software that promotes collaborative communication, easy-to-follow processes, and transparent outcomes that help you complete your pediatric trial.

Introducing Collaborative, Real-Time Editing: Updates to The Cloud Concinnity Platform

Recent Updates to The Cloud Concinnity Platform - Collaborative, Real-Time Editing

As a leader in clinical trial oversight solutions, our team of dedicated engineers and subject matter experts are constantly improving Cloud Concinnity®, our integrated platform for centralizing, standardizing and automating data, communications, processes & reporting.   

We’re excited to announce the following enhancements to the Cloud Concinnity Platform designed to to better serve the needs of our current and future customers.

Improved Platform Feature: Collaborative, Real-Time Time Editing with Tracked Changes

We’re excited to announce the release of live editing with track changes functionality!

These new tools will empower your team with the opportunity to collaborate on finalizing board or committee meeting minutes and other critical documentation simultaneously. They’ll also have the ability to submit minutes for approval at the same time. 

A robust track changes feature will enable your team to see what edits have been made to a document (and by whom), allowing your approval team to accept additions to the minutes at their discretion.

How is This Helpful for Clinical Trial Oversight Boards, Teams, Committees and Administrators?

We’ve heard from several sponsors, CROs and administrators that asynchronous documentation can be a huge time-suck as well as introduce human error/risk to documentation. This is especially true if multiple individuals need to add their data/findings to the same document. 

In legacy systems, board members would need to send around the same document files to add their individual thoughts or make any edits, often through insecure email systems.

The result? 

Too much time wasted waiting on “your turn” with the document. Even worse, ensuring you were working with the latest version of a document could quickly get confusing as multiple versions of the same document would be passed around and renamed by recent editors (version 4 becomes version 6, etc.).

Our solution eliminates both the time-sink and version confusion. Now your entire team can work simultaneously on critical documents through our collaborative, cloud-based technology.

Our Commitment To Improving The Clinical Trial Oversight Landscape

We firmly believe that the future of clinical trial oversight is distinctly digital. Clinical trial oversight committees need the best tools to address today’s challenges. If you have any suggestions for new tools or platform features that you’d like to see become part of the Cloud Concinnity platform, let us know. 

Not yet a customer? See for yourself how Cloud Concinnity is improving operational efficiency and supporting the needs of clinical trial oversight boards and committees.

4 Ways Oversight Boards Can Operate More Efficiently

Oversight boards and committees play a critical role in ensuring the safety and efficacy of clinical trials. Given this responsibility, clinical trial oversight boards must function at peak performance. The more efficient the day-to-day operations of these boards, the more likely the study will be successfully completed on time and under budget. In this blog post, we will discuss four methods for ensuring your oversight boards can execute its duties more efficiently.

Improve Your Oversight Committee's Operational Efficiency With These Four Best Practices

Best Practice 1: Ensure Your Board Is All On The Same Page

An effective oversight board or committee is one that has a mix of medical and scientific expertise, as well as experience in clinical research. Ensuring that you have the right combination of skills around the table will help you accomplish more during internal meetings and reduce the need to bring in outside support to fill a skill gap. 

All members should have a thorough understanding of the study protocol and be up to date on any changes that have been made. They should also be able to have open, frank discussions about the study without feeling like they are being judged.

Honest communication is key to identifying and resolving potential issues before they can negatively affect the clinical trial.

Best Practice 2: Establish A Digital Homebase

If you want to improve the operational efficiency of your oversight board, it’s time to think beyond Dropbox files and shared Google or Microsoft Drives. Look instead for a central, shared, cloud-based home where your team can create, collaborate, approve and store your standardized documents. Ensuring important information like charters, agendas, minutes, and SMP letters during a clinical trial can save days, if not weeks, in labor time spent searching archives and emails for these files.  

Remember, time is money for sponsors and CROs. Time also represents quality of life for patients and families. Improve your communication cadence by ensuring your digital homebase can also act as a one-stop shop for all of the oversight activities that your committee is required to perform around that information.

Best Practice 3: Automate Where Able

DSMBs,DMCs, SRCs and other oversight committees often have to review large amounts of data during clinical trials as a critical function of their role. This can be a time-consuming process, particularly if the data is not organized in an easily accessible way. One way to make this process more efficient is to automate key processes. 

This is another instance where choosing the right clinical trial management platform can improve the operational efficiency of your clinical trial. Eliminate wasted time by automating repetitive tasks like meeting scheduling, document review, decision making and activity documentation with role-based workflows, task deadline alerts for more efficient execution of study oversight protocol steps.

Best Practice 4: Create End-to-End Transparency

To quickly make informed decisions, oversight boards need instant access to relevant data collected during the study. All participants in oversight processes  also need transparency into the current state of any outstanding tasks, assignments, or projects that team members are working on to reduce operational redundancies and eliminate the need for ad hoc status checks. 

Not only does complete transparency vital for improving oversight operational speed, it can also save time in proving security and compliance during the trial to regulatory bodies. A solid clinical trial management platform should come equipped with the tools you need to provide end-to-end transparency, including: 

Global Dashboards: Aggregate important information within and across your study.

System Integration: Make data from multiple sources more accessible.

Robust Reporting: Track and measure a multitude of metrics and activities through automated reporting.

Bonus Best Practice: Choosing The Best Software to Manage Your Clinical Trial

To operate as efficiently as possible, oversight boards and committees deserve the best possible software tools. Cloud Concinnity® was built specifically to meet the unique needs of clinical trial oversight boards. Our platform delivers facilitated access, controlled process, and transparent outcomes that support oversight committees and patient safety while bringing life saving therapeutics to market.

Schedule your free demo of Cloud Concinnity® to learn how our system can help make your next clinical trial a success. 

By far the number one way for oversight boards to operate more efficiently is to be proactive in identifying their needs instead of reactive when problems arise. Whether you're planning your next clinical trial, or you’re in the middle of one, now is the time to examine your systems and processes to identify ways to improve your operational efficiency.

Why Choosing the Right CRO Makes All the Difference

If you want to improve the success rate of your clinical trial, choosing the “right” Contract Research Organization (CRO) is critical. Several factors go into making this decision - from the experience and expertise of the CRO to their ability to meet your specific needs. In this blog post, we'll take a closer look at some of the most important considerations you should keep in mind when choosing a CRO and why finding the right fit can make all the difference in ensuring a successful clinical trial.

4 Benefits of Finding the Right CRO

The right CRO complements your strengths and fills in the gaps of your organization’s expertise.  They add invaluable capacity, while allowing you cost flexibility.  To the extent that a full service CRO is right for you, they can provide you with a wide range of services, including finding and vetting qualified vendors. 

By working with a CRO, you can focus on the core aspects of your clinical trial while ensuring that you get the best possible support and service from your vendors.

1) Expanded Capacity and Expertise

When able, try to work with a CRO that has experience relevant to specific characteristics of your trial - demographic being studied, the technology of the trial, the disease being studied, etc. This way, even if it’s your first clinical trial, you can lean on their experience to drive clinical success and avoid costly mistakes. 

A strong CRO can also provide you with access to their extensive network of contacts in the pharmaceutical and biotech industries, which can be instrumental in helping your drug development efforts.

2) Immediate Access to Patients & Trail Participants

A great CRO fit has the ability to provide a wide variety of clinical trial patients/participants for your clinical study. Discuss the  CRO’s pre-screen process to ensure that you’re enrolling the best possible candidates, which will help you avoid delays in the study due to patient recruitment.  Understand how they meet and monitor enrollment goals and their systems for enhanced patient engagement.

3) Help You Manage Your Budget

A Contract Research Organization can help you stay within your budget by providing accurate cost estimates up-front. This can also help you avoid spending more money than you intended, which can be especially helpful if you are on a tight budget. 

Additionally, a Contract Research Organization can help you speed up the research and development process by providing access to their extensive networks of experts and resources, which can help you further manage your costs. 

4) Access Leading Edge Technology

Regardless of your CRO selection criteria, your final choice needs to be digitally enabled. In this day and age it is probably impossible to overstate the importance of engaging a “Digital-First” CRO.

A strong digital toolset will help your CRO:

• Improve information security, control, and access

• Increase process efficiency and speed

• Improve profitability

• Mitigate risk across the entire ecosystem of the trial

• Facilitate stronger collaboration between EOCs, DMCs, DSMBs, SRCs, Ad Boards

Time is money in clinical trials.  A week delay can cost in excess of $100,000 trial expenses.  On the other side of the ledger, delayed time to market can cost $100,000 a week of lost revenue.  Revenue aside, the benefits to getting life changing treatments to market faster is priceless from the standpoint of patients and their families.  

From a patient safety perspective, strong digital capabilities lead to greater process consistency and communications, both of which contribute to enhanced safety and security.  Understand your CROs full suite of digital capabilities and how they will enhance your study.

Need Help Finding the Right CRO? 

At the end of the day, choosing the right CRO is essential to a successful trial. By partnering with an experienced, reliable, digitally enabled CRO, you can ensure that your trial runs smoothly and efficiently - resulting in better outcomes for patients and sponsors alike.

For more information on choosing the right CRO, contact us today! We have an amazing network of CRO partners. We’d be happy to make introductions and recommendations tailored to meet your specific needs.

5 Common Clinical Trial Management Mistakes (and How to Avoid Them)

Clinical trials are a critical part of the drug development process. Unfortunately, many organizations make common mistakes that can lead to delays or even failures of their trials. Avoiding these mistakes takes awareness, preparation, and an effective trial management process. In this blog post, we will discuss six common clinical trials management mistakes and how to avoid them.

5 Common Clinical Trial Management Mistakes to Avoid

Mistake 1) There is No Project Plan

Project plans are an essential component of a successful clinical trial. At its core, a project plan should include your trial:

• Timeline

• Budget

• Task  List

• Data Collection Strategy

• Oversight plan

• Staffing plan

Timelines and task lists can help your team stay on track so that all tasks are completed on time. An agreed to data collection plan will help ensure your entire team understands the specific data points that need to be tracked. 

Mistake 2) Insufficient Recruitment Plan

One of the biggest mistakes that clinical trial management teams can make is not having a solid plan for patient recruitment. Missing trial recruitment deadlines can lead to delays in enrolling patients, which can impact the overall timeline of the trial. 

For even more insight into developing a recruitment plan, read our recent blog post detailing ways to increase clinical trial enrollment.

Mistake 3) Inadequate System for Patient Tracking and Communications

Another common mistake made by clinical trial management teams is not having a good system to track patient participation and communications. Without these systems, it can be challenging to keep track of each patient’s status within the trial and keep patient engagement high. 

Speak with your management team and make sure they have a system to track patients. You’ll also need to ensure that they have a process and strategy for updating the system regularly. If you must rely on manual systems, investing in exceptional, experienced clinical trial project managers is a must.

Mistake 4) Overlooking Stakeholders

Clinical trials are complex. Frequently you’re juggling multiple entities (EOCs, DMCs, DSMBs, SRCs, Ad Boards, etc.), each representing multiple stakeholders. This can often lead to problems when everyone has a different idea or agenda for how to manage the trial. Stakeholder support and engagement is critical to a successful trial. 

Avoid potential mishaps by having a clear and concise trial management plan that everyone can get behind. Additionally, it is essential to assign specific roles and responsibilities to each partner to help avoid confusion and ensure that everyone knows what they need to do.

Mistake 5) Failure to Invest In Project Management Tools

Project management tools can help you stay organized and on track, essential for any clinical trial. There are many different project management tools available, so find one that fits your needs.

At a minimum, look for clinical trial management tools that:

• Integrate with or serve as your communications hub.

• Accessible via a cloud-based platform.

• Integrate with your existing tech-stack . 

• Can scale with your trial management needs to support multiple, simultaneous trials.

Do your homework and reach out to us.  We’d love to help. The  Cloud Concinnity platform not only does everything described above, it centralizes, simplifies and automates crucial information, processes and tracking that significantly impact the course of a program.

Learn more and schedule your demo here.

By avoiding these common trial management mistakes, you can help to ensure that your clinical trial is successful. If you're not sure how to avoid them, we can help. Reach out to our team of professionals today. 

4 Ways to Increase Clinical Trial Enrollment

Clinical trials are essential to the development of new medications and treatments. However, enrolling participants can be difficult for even the most experienced parties.

The percent of the population that is enrolled in clinical trials is remarkably low. The “high” end of includes the US and the EU at just 5.4% and 4.3% respectively.  From there participation rates drop to around 1% or lower. In addition, a significant percentage of trials do not reach their patient complete participation goals,  nearly half – 40 percent – of cancer trials.  

With both recruitment and retention of adequate trial participants as significant barriers to successful development of new treatments, focusing on better ways to manage clinical trial enrollment is critical. 

This blog post will share four tactics to increase clinical trial enrollment and help you move new treatments and therapies closer to the market.

Increase Clinical Trial Enrollment With These 4 Tactics

1) Set, Measure and Share Enrollment Goals with Partners

You can't improve what you aren't measuring. Before you start integrating new tactics and recruitment efforts, it's critical to establish baseline metrics to determine your enrollment goals. 

At a minimum, you want to ensure you set an initial enrollment goal that aligns with the minimum number of patients required to achieve definitive results. From there, you can establish additional goals. 

Quick tip - be sure all your goals align with your overall objectives. Don't select a number just because,iIt'd be great to hit it. Make sure your enrollment goals have meaning in the trial. 

After defining these goals, please don't keep them hidden away! Communicate them to your team and all partners. Make everyone an active participant in reaching the goal and keep them updated on how enrollment tracks these goals (preferable through a digital platform like Cloud Coconnity).

2) Understand and Plan for Common Objections/Barriers to Participation

By far, the biggest obstacle to driving clinical trial enrollment is trust. If potential participants don't trust any aspect of the trial (from the physicians to the medications), it will be harder to encourage them to participate. 

Trust is a direct result of communication. The more efficient and open you are with your communications about the trial (the independent physicians overseeing the trial, the FDA protocols being followed, etc.), the more likely you will build trust within your recruitment efforts.  

Another way to build trust in your trial is to highlight the role of your oversight committee in your communications. Some potential participants may have a distrust of pharmaceutical companies or of the medical providers associated with them. However, as an oversight committee acts Independently of sponsors and providers, it can help to ease concerns and foster trust in the trial. 

Trust isn't the only obstacle standing in the way of patient enrollment success. Other common obstacles include:

• Location

• Transportation

• Finances

• Competing Obligations

As an exercise, put yourself in the shoes of a potential participant. Identify the potential roadblocks that might interfere with their participation. Then outline how your trial and recruitment plan will address these objections.

3) Optimize Your Recruitment Efforts

Increasing enrollment can be boiled down to one factor for many clinical trials - a high-performing recruitment effort. The better optimized your recruitment strategy, the more likely you are to attract and engage trial participants. Below, we've laid out five key factors of a robust recruitment effort.

1) Zero In On Your Target Demographic

Age/Gender/Medical History are all critical demographic factors in recruiting your ideal audience, but be sure to include additional demographic and psychographic data into your messaging strategy. The more you understand about your ideal participant, the greater the opportunity to tailor your recruitment messaging and trial experience to their needs.

2) Increase Awareness of Your Clinical Trial

No one will be able to join your trial if they don't know anything about it! Dedicate the resources you need to develop and manage a  multi-channel strategy that drives awareness of your clinical trial among your target audience. 

3) Streamline the Application Process

Making a potential enrollee aware of your clinical trial is just the first step in securing a successful enrollment. Cut back on costly ad wastes and reduce form abandonment by streamlining the trail application process and providing a user-friendly enrollment experience. 

4) Provide Incentives for Enrollment

Supercharge your recruitment efforts by offering incentives to participants. As a general rule of thumb, the higher the value of the incentive, the more significant its influence on a participant's decision to enroll. That said, there are diminishing returns. Experiment with various levels of incentives to determine which delivers the best value to your trial. 

5) Engage with Participants Throughout The Trial to Avoid Drop Off

The cost of attracting clinical trial participants can quickly add up. As such, you want to do everything in your power to reduce drop-off and keep retention levels high throughout the trial. One of the simplest ways to improve engagement is to provide consistent communication. The more you're talking with your participants to encourage their ongoing participation, the less likely they will drop off. Consider deploying patient engagement software to do this effectively.

4) Create a Single Source of Truth to Measure and Communicate  Enrollment Information

Siloed data is expensive data.  And it does not provide timely decision support information.  The more barriers to tracking and sharing your data that exist, the less likely your team will be able to promptly analyze and respond to enrollment challenges. Effective measurement and communication of enrollment information requires better access. An integrated software platform can create a single source of truth for decision makers and reporting, as well as eliminate data leakage, loss, and expensive administration. 

Be sure to incorporate a single source of truth for your enrollment data that is available to decision-makers anywhere and anytime. Cloud Concinnity is a powerful cloud-based, integrated platform that drives a higher level of efficiency, speed and risk mitigation while unlocking the value of big data for better decision making.. 

Improve Communication. Enhance Transparency. Drive Enrollment. 

Whether it’s through your Safety Review Committee (SRC), Clinical Trial Steering Committee (TSC) Data Monitoring Committee (DMC/IDMC/DSMB), Clinical Trial Advisory Board, or CRO Oversight,  the more accessible your enrollment data, the more opportunities you have to optimize your recruitment efforts. Strong enrollment comes from having a powerful communication strategy that aligns with data transparency. 

Purpose-built for trial oversight optimization, Concinnity is a single, secure platform where processes that significantly impact the course of a program are managed, executed, and recorded. 

How to Up Your Clinical Trial Data Monitoring Game

Whether you are planning for the data needs of your Safety Review Committee (SRC), Clinical Trial Steering Committee (TSC) Data Monitoring Committee (DMC/IDMC/DSMB), Clinical Trial Advisory Board or CRO Oversight, consistent clinical data monitoring and oversight is critical to a successful clinical trial. Regularly capturing and monitoring your trial's clinical data puts your teams in the position to better understand your trial's status and empowers your team with the information they need to make real-time changes as necessary to optimize your program. 

This post breaks down five steps to defining a successful clinical data monitoring strategy. Following the steps below can save your programs time and money and reduce risk to patients and the program overall.

5 Steps To Defining A Successful Clinical Data Monitoring Strategy

Step 1: Identify Your Most Important Data Points

Clinical trial data can be overwhelming, and it is easy to lose focus on the more essential aspects of the study. A successful data monitoring initiative starts by defining which data points are most important to the analysis, goals, and organizational strategy. 

Consider early the information reporting needs of your oversight teams, both formal and informal, and ensure that the data is timely, reliable, and structured for easy interpretation. Don’t forget to consider relevant data emerging outside of your trial. Data and processes around them spelled out in DMC/DSMB charters and SOPs should be factored into your workflow.

These data points can fall into several categories, including: 

• Patient Count

• Patient Recruitment

• Completed Trials

• Participating Facilities

Step 2: Establish Data Context Format 

Clinical trials increasingly generate more and more complex data. That means more reading and more digesting. This makes developing a way to get a sense of things at a glance more difficult if not more important than ever. The length and content of data requirements for your oversight teams will vary. Committees should define their data content and format needs upfront, bearing in mind the importance of time, trends, and comparisons in their analysis. 

Collecting critical data is essential, but data points themselves aren't a reflection of success or progress. Comparison data points help to provide context to your raw data points. 

By comparing your captured data points to the right metrics, your teams can better determine if the clinical trial is on the path to success or if additional measures are needed to ensure a positive outcome. 

Standard benchmark metrics include: 

• Historical Data & Trends

• Industry or other Comparative Benchmarks

• Internal Goals & Targets

As data presentation is defined, consider the value of providing summary information from past data reviews, interim data, protocol, amendments, recommendations, and any complex medical or statistical issues that influence data interpretation.

Step 3: Implement and Test a Data Capturing Methodology

What good is identifying your critical data points if you're unable to track and capture this information? Before signing off a data monitoring strategy, walk through the collection process for each data point. 

Take the time to identify potential roadblocks and bottlenecks. Are you relying on manual actions to collect your critical data? Or is the collection automated? Where possible, eliminate any manual collection. 

This will help to ensure a smoother data collection process while also eliminating the potential for human errors. 

Step 4: Educating Your Teams on How to Analyze the Data 

Think through your monitoring and oversight teams and identify the individuals that would most benefit from the clinical trial data you're monitoring. Take the time to ensure that they understand how to interpret and analyze the data points they are looking at to support and improve their area of responsibility.

Don’t presume that all participants come to the table ready, willing, and able to understand both the data and the process that they will be engaged in.  Committee members, including DMCs, often have a wide range of experience and training.  Left unaddressed, training needs will impact the cost and success of your program.  

Training programs do not need to be formal or time-consuming. They do have to be well suited to the team or committee itself, so be sure to determine your teams’ training needs upfront.

Critical Components of a Data Training Process Includes:

1. An understanding of why the specific data points have been chosen.  

2. A walkthrough of how the data is collected.

3. Guidance on how the data points relate to established goals/benchmarks.

4. Recommendations on how to analyze the data. 

5. Workflows on any actions needed based on the data.

6. Key elements of data security, including the importance of protecting unblinded data

Step 5: Select The Right System for Your Data Needs

The clinical trial oversight ecosystem is complex and highly regulated. Unfortunately, the work of most monitoring teams and committees is mired in 20th-century point solutions - creating data and process insecurity and variability. 

These systems are often home-grown, dated & generic, disconnected, highly manual, and error prone. They increase costs, risks & delays at a time when we need trials that are fast, safe, and efficient. 

Clinical trial oversight depends on accurate, up-to-date information that is securely and quickly available to decision-makers. Centralizing this information securely in the cloud means the right people will have instant, 24/7 access to the right information they need. 

What’s more, rather than trial updates needing to be sent over insecure connections, the information can be uploaded or updated automatically, when it’s ready, and is immediately available. At the same time, the information is more private and protected than ever because it is only being shared within a single, secure platform that has high-level privacy protection.

Improve Your Clinical Trial Data Monitoring with Cloud Concinnity 

Cloud Concinnity is an integrated platform that centralizes, simplifies, and automates control of data, communications, process management & reporting while unlocking the value of big data. Systems like Cloud Concinnity can make it easier for your team to review the data collaboratively while providing a centralized hub for data capturing processes, measurement strategies, and reporting. 

Data collection, monitoring, and reporting are critical to a successful clinical trial. By taking the time to define your data collection intentions, you're more likely to experience long-term clinical success.

The Concinnity Company Partners with Neuren Pharmaceuticals

“We are extremely happy to be Neuren’s partner in improving the lives of people with neurodevelopmental disabilities” said Nancy Falls, Concinnity Company CEO. Neuren Pharmaceuticals is developing new therapies for highly debilitating neurodevelopmental disorders that emerge in early childhood. Currently there are no highly effective or disease-modifying drugs approved for these conditions. Because these are serious medical conditions with unmet need, speed, as well as quality, is of the essence.

In addition to seeking regulatory fast tracks, Neuren sought to ensure superior security and efficiency in its clinical trial oversight process.  In search of the best software solution for managing these important clinical trial oversight committees, Neuren found The Concinnity Company and its Cloud Concinnity® platform. 

“Concinnity is extraordinarily functional and comprehensive clinical trial oversight software: a single, secure platform where all meetings, documents and processes can be centralized, automated, monitored and generate a complete audit trail.” said James Shaw, Vice President, Clinical & Regulatory Operations. “By partnering with outstanding CROs and Concinnity, we can be assured of speed, security and efficiency in our oversight processes.”

Neuren’s  use of Concinnity’s innovative software supports the Data Safety and Monitoring Committees’ oversight of 3 trials testing the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with  3 syndromes: Pitt Hopkins Syndrome, Phelan-McDermid Syndrome and Angelman Syndrome. Implementation of the Cloud Concinnity platform is expected to reduce any administrative burdens so that the DSMC can complete its work securely, thoroughly and quickly by improving  meeting coordination, document sharing and general workflow practices.

“The future of clinical research depends on the kind of improvements in information and communications access and control, process consistency and tracking and outcomes transparency that are only achievable with smart technology,” said Falls. “This is especially true trials for our most vulnerable patients, ones that involve complex or adaptive trial designs, tight monitoring of dosing escalation, the analysis of multiple and complex data streams, and rigorous regulatory involvement.”

About Neuren:

Neuren is developing two new drug therapies to treat multiple serious neurological disorders that emerge in early childhood. The lead drug compound, trofinetide, is currently in a Phase 3 clinical trial for Rett syndrome and has completed a Phase 2 clinical trial in Fragile X syndrome. Both programs have been granted Fast Track designation by the US Food and Drug Administration (FDA). Neuren has granted an exclusive licence to ACADIA Pharmaceuticals Inc. for the development and commercialisation of trofinetide in North America. Neuren plans to initiate Phase 2 trials for a second drug candidate, for each of PhelanMcDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2022. Because of the urgent unmet need, all five programs have been granted “orphan drug” designation in both the United States and the European Union

Why Adaptive Design Clinical Trials Demand Stronger Digital Capabilities

Clinical trials are moving faster than ever, and decisions about starting, stopping, continuing or changing protocols are happening in real time, across geographies. It is critical to have a digital home that centralizes, simplifies and automates all of the crucial information, processes and tracking that can significantly impact the course of a program. 

Conventional trial design and oversight has been pushed to evolve and change in the two years since the FDA first released their “Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry,” and the Covid-19 pandemic has only hastened the shift, pushing adaptive trial design to the fore. 

As adaptive trial design emerges as part of the new normal, clinical trial oversight design must embrace smarter software like Cloud Concinnity® to adapt and thrive.

Adaptive trial design takes clinical research to the next level, yet it presents some key challenges that come with speed and responsiveness. Challenges and demands like 1) More Meetings, 2) More Decisions, 3) Tighter Timeframes, 4) More Complex Data, 5) More Data Streams and 6) Higher Stakes come part and parcel with adaptive trial design.

For oversight teams, smarter software holds the key to addressing and solving many of these challenges. Here’s how: 

6 Ways Smarter Oversight Software Meets the Demands of Adaptive Trial Design

1. More Meetings? Smarter Software Means Better Process Automation

Adaptive trial design means more data and more decisions to make — and that means more meetings to discuss and make those decisions. With an oversight team spread out across the world and across time zones, manually managing standard operating procedures and charter mandates can create significant delays. Using a platform that automates meeting management end to end gives administrators broad and deep capabilities like automated scheduling, invites, reminders, data aggregation and decision documentation making less work for everyone, and more time for deep thinking. 

2. More Decisions? Smarter Software Lets You Stay Connected, Secure & Well-Informed

The data, information and consideration it takes to successfully oversee and manage an adaptive trial means lots of reading and questions. Every bit of that information must be kept confidential, which is easy with smart software that has the most advanced security protocols. What’s more, smart software can keep all communication during the decision-making process secure, so there’s no need to risk email, text, or video chats that could be hacked or leaked. 

3. Tighter Timeframes? Smarter Software Centralizes & Streamlines Everything 

We know that “Adaptive clinical trials can be completed sooner than trials with conventional (non-adaptive) designs,” so there is every reason to expect this faster, more nimble trial design to be widely adopted. And with the potential for speed comes tighter timeframes. Centralizing access, process, and outcomes means everyone on the oversight team need only check and stay updated on a single platform. Centralized means simpler, and simpler means faster. In addition, getting together as a team simultaneously to discuss everything, every time can be unrealistic. That’s why the secure, asynchronous communication that smarter software offers is critical. Share documents, have conversations and send messages across time zones and geographies. 

4. More Complex Data? Smarter Software Simplifies Everything with a Master Dashboard

Adaptive trials deal with and generate more complex data than conventional ones. That means more reading and more digesting, but it doesn’t change the fact that we all need a way to get a sense of things at a glance. A single, secure hub for the aggregation, review and submission of data for oversight committees, sponsors & regulators makes that possible with a master dashboard and analytics. Customizable, global dashboards that aggregate key information within and across studies gives unprecedented visibility to key study results and metrics 24x7.

5. More Data Streams? Smarter Software Offers Powerful Data Integration

Adaptive trial design means more data streams, more information, and more decisions to make. A platform that is integrated across the eclinical ecosystem ensures data integrity from trial planning all the way through regulatory approval and beyond. Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF. 

6. Higher Stakes? Smarter Software Delivers End to End Process Management

“Unlike conventional designs, where the learning typically occurs after the trial is completed, adaptive designs intend for continual learning as the data accumulate.” Continual learning and adaptive decision-making means more to manage, and that’s why the process management engine of smarter software is so critical. End to end process management is the ideal vehicle to power continual learning for a dispersed oversight team.

In the end, it’s clear that adaptive trial design is the way of the future, which means oversight teams will need to be more adaptive as well. Smart software is the only answer that lets teams step up to the next level while also maintaining or improving quality. 

6 Data Security Benefits We Deliver for Clinical Trial Oversight

At Concinnity, our #1 concern is data security for clinical trial oversight. 

As the world woke up to the dawning new normal of 2022, we saw thought leaders across healthcare pointing toward a digital future. Aman Khera, the Global Head of Regulatory Strategy at Worldwide Clinical Trials, cited “Digital Health” and digital transformation as the top trends shaping clinical trial regulations in 2022, noting that everyone from the WHO to the FDA and EMA are looking closely at how digitization tools should be used, and at how data is stored and used. BCG recently proclaimed that healthcare’s new reality is dynamic, digital, and here to stay. 

Security for digital data and communication is what makes the digital future of clinical trial oversight possible.

At Concinnity, we have focused on data security from day one. We know that digital security for all stakeholders at every level of the process — from study sponsors and CRO’s all the way down to each individual study participant — is an inherent and primary need to pave the way for this digital future. It is our security features that make our platform a game-changer, by making Cloud Concinnity the  most secure platform available for clinical trial oversight management.

Concinnity is structurally designed to adhere to the highest standards of data security, including the special protections required by law for health information by HIPAA and other related regulatory requirements. 

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Here are the top 6 data security benefits we deliver for clinical trial oversight:

1. Separate Workspaces for Blinded and Unblinded Study Teams

   At the very core of clinical trial oversight is the need for certain iron-clad data separation. To ensure this, Cloud Concinnity creates a “physical” separation of blinded and unblinded data that eliminates the risk of any stakeholder sharing unblinded information. In short, we make it virtually impossible for oversight data accidents to happen. 

2. Superior UI/UX (usability) that Improves Security

   The simple, clean, intuitive user interface that makes Concinnity a joy to use also makes it more secure. Our superior UI/UX and deep structural platform integrity dramatically reduces any risk of user error and of any individual using the software incorrectly or accidentally going around the system. 

3. Patent Pending Workflow Engine that Safeguards Processes and Data

   We understand that procedures and processes are as important to data security and compliance as software structure. Manual processes by nature are subject to human error and vulnerable to the loss of institutional knowledge during staffing transitions. Our proprietary workflow engine includes features that easily automate best practice processes across a portfolio of studies, protecting data and reducing the risk of variability or non-compliance. 

4. Comprehensive Oversight Solution Protects Patient/Sponsor Data

   We built capabilities and productivity integrations that allow participants to do all of their clinical trial oversight work on a single, secure platform. This eliminates the significant risk introduced by transmission of sensitive information into and out of various non compliant applications, from email on multiple servers to scheduling, video conferencing, eSignature and document editing apps where data insecurity is rife.

5. Integrated Platform Ensures Data Integrity from trial planning all the way through regulatory approval and beyond

   Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF. Robust data integrations remove the risk of data loss, leakage, and unblinding. Automated data integrations protect clinical trial data and security on the way in, eliminating the need for manual or episodic uploads. Direct integrations with reporting and document management systems protect critical decisions and auditability on the way out. 

6. Regulatory Compliance That Goes Above and Beyond

   Cloud Concinnity is compliant with all ​​21 CFR Part 11 regulations, and maintains a host of further regulatory compliance credentials. We maintain SOC2 compliance, and use further information security elements or setup elements like 2-factor authentication for login, plus role-based and configurable permissions to control access to specific data/content/information.

The bottom line? Cloud Concinnity is by far the most secure choice to manage clinical trial oversight operations, and the only clinical trial oversight software on the market equipped to fully make the digital future of clinical trial oversight possible. 

The Year Ahead: Big ideas for the future of clinical trial oversight.

What does it take to build the future? What mindset does a team need to create breakthrough clinical trial oversight software that will impact millions of patient outcomes?  

It takes innovation, commitment & the courage to lead. 

While the world continues to wrestle with Covid, we at Concinnity have grown even more committed to our role in bringing life changing treatments to market more quickly, safely and efficiently. The future of clinical trial oversight is undoubtedly digital, and utilizing smart software to facilitate information access, process control and outcomes visibility is imperative. 2022 will be a pivotal moment for our industry. We feel like it is our moment. Why? As one of our team posted this week: 

“The challenges of the clinical trial oversight ecosystem feel like they were created for us; a place where we can be innovative and idealistic where the ceiling will be created and determined by us.”

To start off 2022, we asked ourselves: What excites us about the future of clinical trial oversight? There were too many good ideas and insights to publish everything, so we’re offering a condensed look behind the scenes at what our team is thinking. 

Here are a few of the big ideas driving our work as the calendar turns to the new year:

DOING OUR PART TO HELP HEAL THE WORLD

Given that the revolution/evolution of the clinical trial ecosystem continues, we’re excited and motivated by the impact Concinnity's technology can make on helping to heal the world. We'll be providing crucial services to pharmaceutical companies and DSMBs that will be called upon to make faster decisions about the safety and efficacy of clinical trial results.

MAKING A DIRECT HUMAN IMPACT

We are proud to be part of an industry that is making a direct impact on the human race. One of our customers is the first pharmaceutical company ever to show positive results in a phase 3 neurological disorder. We are delighted to be working with such passionate, innovative professionals. Need we say more?!?

HELPING CUSTOMERS DO MORE WITH LESS

In the face of shrinking support resources across industries, we're poised to enable our customers to do more with less.

MAKING TECHNOLOGY THAT CHANGES THE WORLD

As Covid becomes endemic and more a part of a new normal, we anticipate seeing a rapid uptick in drug trials. We see this year as the time when both sponsors and the CROs recognize the need to use technology to make the management of DMCs both more secure and more efficient.

In the year ahead, we know that changes and challenges to the industry will continue. But the good news is, we are powering the smart, digital future of clinical trial oversight with the most functional and comprehensive clinical trial oversight software on the market. And thousands of women and men across the globe are committed to the success of trial operations in the midst of unprecedented hardship.

Our belief in the power of our collective hard work and innovation gives us faith in our shared future. We believe we will look back on 2022 as a year of great progress. Let’s lead and innovate together!  

Learn more about how Cloud Concinnity can support your clinical trial oversight. 

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Want more forward-looking insight? Here’s a sample of our deepest insights on what 2022 will bring: 

A Look Ahead: 4 Clinical Trial Oversight Trends That Will Guide 2022 and Beyond

Thinking Ahead: 5 Post-Pandemic Priorities for Clinical Trial Oversight

Beyond COVID: 3 New Standards for Clinical Trial Oversight

Our 3 Top Articles from 2021: A Year End Review

2021 has been a year of rapid, seismic change in clinical trials and clinical trial oversight. A year ago as we approached the end of 2020, COVID vaccines were only just starting to get approved. World travel was still dramatically restricted. Joe Biden was not yet inaugurated. In short, it was a lifetime ago.

As a world and as an industry, we have come together and made it through. 

At Concinnity, we have grown even more passionate about our role in bringing life changing treatments to market more quickly, safely and efficiently. The future of clinical trial oversight is undoubtedly digital, and utilizing smart software to facilitate information access, control process and highlight outcomes is imperative.

As the year comes to a close, we wanted to share a few of our favorite insights from this past year. We invite you to look back with us, and take a moment to pause and reflect on what challenges and changes the year has brought for you. 

1. 4 CRITICAL CONSIDERATIONS FOR CLINICAL TRIAL OVERSIGHT

“In this age where digitally enabled productivity gains are accelerating the fourth industrial revolution across industries, it means identifying and making critical changes. Boston Consulting Group has found that 70% of digital transformations end in failure, and that just 30% of companies are succeeding. So what does it take to make sure you and your oversight teams are in that top third?”

In this post, we explored the most pressing issues for everyone in clinical trial oversight to grapple with. Do you agree with where we landed?

2. 5 NEW WAYS CLINICAL TRIAL OVERSIGHT PRACTICES CAN RISE TO TODAY’S CHALLENGES

“Today’s turbulent environment has precipitated an unprecedented level of pressure on sponsors, CROs, and the ecosystem of oversight committees needed to create and conduct a clinical trial. The accelerated rate of change means that if these key stakeholders aren’t effectively engaging key issues of strategy and risk, they are competitively handicapped at best and, at worst, in risk of crises. We look at some of the old processes that are being challenged -- and how Cloud Concinnity can facilitate critical transformation.”

Here, we focus on the best practices and tactics that can make a huge difference in how effective processes can be. It’s a perfect list to check if your oversight teams are doing everything they can.

3. HOW INNOVATION MUST ADDRESS THE ONGOING IMPACT OF COVID-19 ON CLINICAL TRIAL OVERSIGHT

“It is clear that innovation driven by digital transformation will drive the future of clinical trial oversight. Not only will the coming years be challenging to navigate, they will also push all of us to work together to create a truly innovative clinical trial oversight ecosystem.”

Finally, we look at the biggest issue of the year – COVID-19 – and how it has impacted the industry. Whether long-term or short-term, COVID has changed how we do almost everything.

In the year ahead, we know that changes and challenges to the industry will continue to demand innovation. We are committed to powering the smart, digital future of clinical trial oversight. Cloud Concinnity® is the most functional and comprehensive clinical trial oversight software on the market: a single, secure platform where all meetings, documents and processes can be centralized, automated and monitored, generating a complete audit trail., We look forward to working with you and your team in the new year. 

Learn more about how Cloud Concinnity can support your clinical trial oversight

10 Remarkable Clinical Trial Stats Illuminating the Future of Oversight

As the year comes to a close, we are reminded how deeply important great clinical trial oversight is to both the clinical trial ecosystem and to the world. COVID has pushed us all to be more thoughtful, resilient and efficient in the work we do, and what we are all living through is truly a turning point for how clinical trials happen. 

Improving clinical trials and clinical trial oversight for the benefit of every stakeholder -- from sponsors all the way through to patients -- is one of the most compelling opportunities of our time. Nothing less than the future of healthcare is on the line, and every step in the process counts. As creators of breakthrough trial oversight software, we are committed to making clinical trial oversight more efficient and effective, and we see ways to support stakeholders at every level of the process.

Today we zoom out and take a look at some of the statistics behind clinical trials and oversight work to see how devastating delays and disruptions can be, opportunities to address those problems, and explore what all of this may reveal about the future of clinical trial oversight. 

CLINICAL TRIAL OVERSIGHT STATISTICS -- THE BIG PICTURE

Providing safe and effective treatments has never been more important, and that demands focus on improving the effectiveness of oversight. In the short term, we continue to see the critical importance for addressing COVID-19, but in the longer term it’s clear that we must address the growing healthcare needs of an aging global population. 

• 1967: The year that an NIH external advisory group “first introduced the concept of a formal committee charged with reviewing the accumulating data as the trial progressed to monitor safety, effectiveness, and trial conduct issues in a set of recommendations to the then-National Heart Institute.” While DMC’s had been a part of some clinical trials since the 1960’s or earlier, it has been about 55 years since they were formally recommended by the NIH. (source: https://www.fda.gov/)

• $198 billion: Estimated global spending on Pharma R&D in 2020. (source: statista)

• 18,582: The number of drugs currently in the R&D pipeline as of October 2021. (source: statista)
  

Oversight innovation through smart software means that the hundreds of billions spent in drug development will be used as efficiently and effectively as possible. The post-COVID oversight world will live online, and we are already shaping how it can build the future on top of the first 50 years.

CLINICAL TRIAL OVERSIGHT STATISTICS -- COST OF DRUG DEVELOPMENT

It is shocking just how costly study delays and disruptions are, and a major challenge is how normalized study disruptions are. Smart software in clinical trial oversight will continue to grow and expand as an effective tool for mitigating those risks and costly delays and disruptions.  

• $2.6 billion: The average cost of developing a drug in the United States, as of October 2021. (source: statista)

• $600,000 and $8 million: What each day of trial delay during a product’s development and launch can cost sponsors. (sources: pharmafile and antidote)

• 9 out of 10: Number of trials that require the original timeline to be doubled in order to meet enrollment goals. (source: antidote.com)
  

Smart software is an easy-to-implement, powerful tool for efficient oversight that has immediate impact on data security and oversight committee communication. There is no going back to how things were before COVID, and we are thrilled to be driving innovation across the clinical trial oversight ecosystem that will impact stakeholders and processes across the board.

CLINICAL TRIAL OVERSIGHT STATISTICS -- THE IMPACT OF COVID

New study launches took a massive hit in 2020 when the initial COVID outbreak happened, and the ripple effect is still making an impact across the clinical trial oversight ecosystem right up through the end of 2021. What we see is that COVID-19 slashed the number of active studies, pushing everything back, and making the queue for new studies even longer.

• 57%: The percentage of studies initiated in the U.S. from February to May in 2020 vs. what would have been expected had the pandemic not occurred. (sources: pubmed.ncbi.nlm.nih.gov and nature.com)

• 77%: The percentage of studies initiated outside of the U.S. from February to May in 2020 vs. what would have been expected had the pandemic not occurred. (sources: pubmed.ncbi.nlm.nih.gov and nature.com)

• 40,000: Number of already-enrolled patients impacted by the disruption of trials by COVID-19 (source: centerwatch.com)

• 44%: Percentage of the more than 2,600 clinical trials stopped in the first five months of the 2020 that cited the COVID-19 outbreak as the cause. (source: centerwatch.com)

Moving forward, the clinical trial ecosystem will need newer, better and ever more efficient ways to oversee studies, both to make up for lost time and to manage the ever-growing number of new studies. Smart software is the answer, and the way forward.

With all of this in mind, shouldn’t your clinical trial oversight team use the best possible oversight software? 

Learn more about how Cloud Concinnity can support your clinical trial oversight

How DSMB Expert Teams Create Magic

In the decades since DSMB’s were first established, their makeup and structure may have changed, but their mission has stayed the same: To protect the safety of patients, ensure the integrity of data and determine treatment efficacy in clinical trials. To do this, DSMBs must create an important sense of trust during the drugs and treatment development process -- a sense of trust that will ripple out to stakeholders in every direction. 

What was once a team of experts operating behind the scenes has been thrust into the spotlight during the pandemic. Indeed, DSMBs today not only need to perform their duties, but they need to do them in an unbiased, consistent and documented way that will hold up to public scrutiny. So, how can clinical trial oversight teams create that magical sense of trust in a study and its outcomes that translates numbers and research into something everyone can put their faith in? 

Today, DSMBs and other expert clinical trial oversight teams can go above and beyond in their work to create magic by leveraging smarter software and the advantages and opportunities it can offer.

1. LEVERAGE NEW STRATEGIC COMMUNICATION NORMS AND EXPECTATIONS TO BUILD NEW STANDARDS FOR EXCELLENCE & TRUST

When a DSMB is equipped with state of the art cloud software for communication and data management, their work can go from “keeping up” with the pace of the study to driving greater speed and safety and process transparency to their important work.  DSMBs so levered with smart technology can set new standards for excellence and trust. Smart software allows DSMB members to securely communicate between meetings, making sure that everyone is updated along the way and that people are ready to make decisions faster.

This means the DSMB members and ad hoc support can begin the study knowing that they will all be asynchronously available to each other throughout the study, not just during scheduled meetings. By setting the expectation of strategic conversations between meetings, the continuity of the study oversight can be supported. 

2. ENGAGE AD HOC SPECIALISTS TO SUPPORT AND STRENGTHEN OVERSIGHT WITH ASYNCHRONOUS WORK IN REAL-TIME

In addition to the “1) One or more experts in the clinical aspects of the disease/patient population being studied, 2) One or more biostatisticians, and 3) Investigators with expertise in current clinical trials conduct and methodology” that the NIH specifies every DSMB must include, the NIH also states that ad hoc specialists can be brought in to advise at any time. Whenever possible, this is an excellent option, and one of the major obstacles has always been geography. 

The pandemic has forced us all to work differently, and with the normalization of remote work, so too are we seeing an opportunity to normalize and leverage ad hoc specialists for DSMBs. Oversight teams who want to bring in ad hoc specialists to support and strengthen their oversight can use smarter software to offer secure access to study data and secure communication with the rest of the team. A single, integrated, cloud-based platform supports virtual and asynchronous work in real-time.

3. DEEPEN AND SUPPORT APPROPRIATE EXCHANGE BETWEEN CRO/SPONSOR AND DSMB

Smart software, platform architecture, as well as role-based permissions, can facilitate and protect communications for faster, safer clinical trials. Because every DSMB is part of a study that has a CRO and/or a sponsor, there will need to be communication between the DSMB and these organizing entities. But those communications also need to be highly regulated to protect data and independence. All participants must have direct, easy access to what they need, when they need it, but must be blocked from what they should not see. 

At the same time, smarter software can offer the opportunity to make communication and updates more frequent and effective from the DSMB to the CRO/Sponsor. Because study data and communication will live in a central, secure location that needs less upkeep, this opens up opportunities for the DSMB to communicate in new and supportive ways. Indeed, when the work of the DSMB for clinical trial oversight gets easier, everyone’s work gets easier -- and that is great for patients and drug development. 

Smart software allows for faster thinking at a time when we need it most.  At a time where we are all still adjusting to post-pandemic norms it gives teams a chance to adapt to these new normals. But most of all, the forward-thinking teams that embrace smart software for their work can create the much-needed trust in the process and the invaluable treatment fruits of their efforts. This is the real magic. Can your trial oversight team create it?

Click here to access our essential guide to the future of clinical trial oversight

3 Advantages of Cloud Transformation for Clinical Trial Oversight

As the world adapts to the new normal of life in the wake of COVID, thought leaders are looking deeply at how industries are transforming through the digital cloud, AI and other smart technologies. In healthcare, the digital cloud transformation is already well underway, as evidenced by this analysis of What [healthcare] payers and providers can learn from successful cloud transformations in other industries. 

The opportunity for digital cloud transformation to impact the clinical trial oversight ecosystem has arrived, offering myriad advantages to sponsors, CROs and DSMBs. Those who start now can still be ahead of the digital curve.

Today, we look at 3 advantages that cloud transformation offers to clinical trial oversight players, if they anchor their transformation in enterprise, integrated platforms.

1. FACILITATED ACCESS TO INFORMATION & COMMUNICATIONS EMPOWER DSMBs TO MOVE FASTER & MORE SECURELY

Clinical trial oversight depends on accurate, up-to-date information that is securely and quickly  available to decision makers. Centralizing this information securely in the cloud means the right people will have instant, 24/7 access to the right information they need. 

What’s more, rather than trial updates needing to be sent over insecure connections, the information can be uploaded or updated automatically,when it’s ready, and is immediately available. 

At the same time, the information is more private and protected than ever because it is only being shared within a single, secure platform that has high level privacy protection. 

Truly, we are seeing a revolution in the way a DSMB can do its work.

2. CONTROLLED PROCESSES BENEFIT COMMITTEE EFFICIENCY AND CONSISTENCY

Hosting clinical trial oversight processes in an integrated, cloud-based platform will help formalize and automate many steps of the DSMB workflow. Scheduling meetings will be streamlined, creating reports will be simplified and access to information will be centralized. In short, what has always taken a series of phone calls or email threads can now be done with a few clicks -- or automated altogether.

The oversight administrator will have an easier way of creating repeated, trusted processes for members; the DSMB as a team will be able to complete key tasks on their own time while engaging in asynchronous conversations, and every stakeholder involved in the study oversight will have a simple, central authority available for access when they need it. 

Processes will drive the timeline, not the schedules of individual people. A cloud based integrated platform will make everyone’s life easier, and the oversight of every study more efficient. 

3. TRANSPARENT OUTCOMES PROVIDE BETTER RISK MITIGATION

A further advantage of cloud-based integrated transformations is that all outcomes are much easier to track and are more transparent, allowing for improved risk mitigation. When information and processes live in the cloud, they are easily trackable, which gives administrators the unique opportunity to analyze activity after the fact. Over time, administrators will be able to observe and address patterns and optimize the risk management of a study, accelerating the overall risk mitigation processes. 

On an even broader scale, CRO’s and sponsors will be able to see and review aggregate data within and across studies and portfolios, offering insight into best practices that help manage risk in studies currently underway, and inform next practices for studies currently in the pipeline. Overall, risk mitigation will benefit from the transparency of outcomes that promote improvement for all.

The future of clinical trial oversight is powered by smart cloud transformation that is happening across industries and is already changing every corner of the healthcare industry. 

Is your oversight team ready to be part of this cloud transformation?

Learn more about how Cloud Concinnity can support your clinical trial oversight

How Innovation Must Address the Ongoing Impact of COVID-19 on Clinical Trial Oversight

COVID-19 has deeply impacted every aspect of clinical trial oversight, but we are only now beginning to explore its ongoing impacts and effects. In looking at “the next wave of healthcare innovation,” McKinsey zooms in on how innovation can transform longstanding inefficiencies, and how technology is the key to unlocking a future that accelerates that innovation. 

It is clear that innovation driven by digital transformation will drive the future of clinical trial oversight. Not only will the coming years be challenging to navigate, they will also push all of us to work together to create a truly innovative clinical trial oversight ecosystem. 

Today, we highlight 3 areas where innovation is called on to address the ongoing impact of COVID-19 across the clinical trial oversight.

1. OPTIMIZE PROCESSES AND REDUCE COSTS TO INCREASE PATIENT BENEFITS

While research and study protocols typically only change over long periods of time, when COVID-19 arrived in 2019, these protocols and study models had to change literally overnight. The answers about how best to manage oversight of a study in today’s environment are still far from settled. 

Oversight processes need to be optimized for efficient, effective remote work. Optimizing oversight processes will support getting new drugs to market faster, thereby positively impacting patients down the line. At the same time, optimizing oversight processes for remote work creates countless opportunities for reducing costs. This is where oversight innovation -- driven by smart technology -- can impact the bottom line of every stakeholder in the process.

2. STAY AHEAD OF THE PACK TO GET A JUMP ON FUTURE INNOVATION

Understanding that smart technology will drive the necessary oversight innovation is one thing. Being the group who researches, understands, and chooses the right solution is the real step that will set you apart from the pack. And staying a step ahead of competitors is critical. We have a whitepaper full of deep insight into exactly why and how. 

Getting started in 2021 on the innovations that will serve you in 2022 and beyond is the key to getting ahead of the pack. It is tempting to employ short term tech solutions that work “for now,” but it is the stakeholders who choose to plan for the ongoing impact of COVID-19 who will thrive in the next chapter of clinical trial oversight. 

3. STAYING ON TOP OF REGULATORY AND COMPLIANCE CHANGES TO SET THE TONE

Smarter software and innovative approaches to the impact of COVID-19 does not stop with optimized processes and market advantages. COVID-19 is also impacting the regulatory and compliance environments of every industry.

We need innovative ways for oversight committees to stay updated personally and as a group on these changes. And, we need innovative ways for remote oversight teams to quickly get on the same page about how study protocols and other procedures and requirements for final documents are changing. All of this is best accomplished with smart technology. 

The future of clinical trial oversight will be driven by innovation driven and digital transformation. will drive the future of clinical trial oversight -- it’s the only way to stay on top of the ongoing impact of COVID-19.

How is your team jumpstarting oversight innovation in your ecosystem?

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Cloud Concinnity can support your clinical trial oversight

Thinking Ahead: 5 Post-Pandemic Priorities for Clinical Trial Oversight

In their ongoing series, McKinsey talks about “the next normal” and the importance of “emerging stronger from the coronavirus pandemic.” We at Concinnity are committed to doing our part to make sure that the clinical trial ecosystem can do just that — emerge from the challenges of the coronavirus pandemic with even greater focus, speed, security and scale than before.

Today, we look at the 5 priorities that McKinsey calls out for CEO’s as we build the next normal, and think about how these recommendations apply to the emerging imperatives for the clinical trial ecosystem. 

1. HARNESS THE CLOUD

Responsible, forward-thinking oversight must be built around the cloud. McKinsey writes that “By 2030, there could be $1 trillion at stake — and it’s likely that early adopters will win the lion’s share.” In clinical trial oversight, we believe the same will be true — the lion’s share of the benefits, by way of speed and scale for new drug development, will go to those who leverage cloud technology to supercharge the effectiveness of their oversight teams and committees. 

2. RECONSIDER SUSTAINABILITY

Here, the focus is on how clinical trial oversight can do its part to adapt to climate change. At first blush, this feels largely unrelated. However, building operations around cloud technology, ideal for remote work during the pandemic, will also make it easy for oversight teams to reduce their travel and commutes for the long term. Indeed, cloud technology is a prime example of how a combination of innovation and necessity can accelerate growth that is good for the planet, the people, and the bottom line.

3. LEVERAGE YOUR TALENT

While oversight teams are often not together for the long term, that doesn’t mean that being part of trial oversight work can’t be an efficient and educational experience for all participants. Access to an ever-growing library of thought leadership, best practices and automation can help everyone on the team optimize their time, get more done and enjoy the work. Cutting non-value added tasks and work from the process frees up time for thought, higher level taks and learning.  Oversight committee members and support teams alike are precious resources to be used more wisely through better systems, content and processes.

4. EMBRACE SPEED

The promise of cloud technology to support faster, more efficient work is unparalleled. The pandemic has pushed us all to adopt the agile, iterative work methods that will serve us even more beyond the pandemic. When professionals can work from anywhere, they work faster. When mundane tasks can be automated, there is more time (and energy) for the hard work, which means it gets done faster and better. And when clinical trial oversight is faster and more focused, breakthrough drugs and therapies can get to market and serve more patients.

5. RECONNECT WITH PURPOSE

While geography once served as a limiting factor for finding mission-aligned oversight team members, cloud technology enables finding and engaging the optimal clinical trial oversight talent. And finding meaning in work is no longer a “nice to have”. It can be a driving factor in how oversight teams are put together. This will go a long way toward aligning everyone involved around a shared purpose, supporting the speed and scale aspects of new drug development. 

As McKinsey has pointed out, some priorities will rise above the rest as we move into a new reality beyond the pandemic. These same priorities can focus and drive the post-pandemic priorities for every stakeholder in clinical trial oversight. 

Are you ready? 

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Cloud Concinnity can support your clinical trial oversight. 

Concinnity Featured As Part of the Venture Atlanta Showcase

We are honored to announce that Venture Atlanta has selected us as one of the top technology companies in the Southeast, and that Concinnity will be featured at the upcoming Venture Atlanta Conference as a Software Showcase company. 

Venture Atlanta is an annual collaboration between the Atlanta CEO Council, Metro Atlanta Chamber, and the Technology Association of Georgia (TAG) and one of the premiere technology innovation event in the Southeast. 

Allyson Eman, CEO of Venture Atlanta, says: 

"Venture Atlanta has become the authority for recognizing technology innovation across the Southeast and beyond, connecting the best and brightest innovators with top-tier, national investors and other leaders in our tech ecosystem."

Venture Atlanta has been selecting, supporting and connecting the most promising tech companies and bringing in top investment firms from across the nation to meet them for 14 years. The annual conference has helped 500+ companies launch and raise $6.5 billion in funding to date.

Nancy Falls, our CEO, says: 

"We are delighted to receive this recognition. Technology enabled productivity gains are the future. Venture Atlanta gives us the opportunity to advance this future where we need it most. The needs of clinical trial boards and committees parallel those of other governance, risk and compliance teams. But, as the pandemic has made clear to most of us, these are some of the most complex and pressing needs of our time. Supporting clinical trials is the highlight of our work."

We are thrilled to be part of Venture Atlanta 2021. COVID-19 has disrupted almost every aspect of clinical trial management and oversight. We know that smart software will power the emerging future of clinical trial oversight.

Cloud Concinnity® provides the most functional and comprehensive clinical trial oversight software on the market: a single, secure hub where all meetings, documents and processes can be centralized, automated, monitored and generate a complete audit trail. We are proud that Cloud Concinnity® enables developers of new therapies to bring their treatments to market faster, at a lower cost all while reducing risk to Sponsors, Clinical Research Organizations (CROs) and patients. 

Click here for the full press release. 

Learn more about how Cloud Concinnity can support your clinical trial oversight.