7 Data Protection Tips for Data Safety and Monitoring Boards

As data privacy becomes increasingly important in the clinical trial space, data protection, in turn, becomes a higher priority for data safety and monitoring boards. To ensure the data you are storing is secure and private, clinical trials must implement strong data protection measures to keep their clinical trial data secure. Here are 7 data protection tips for data safety and monitoring boards. 

7 Ways Data Safety and Monitoring Boards Can Improve Data Protection

Reviewing and Establishing a Data Protection Policy for Your DSMB

Improving data protection starts by creating a data protection policy. Your data protection policy will provide answers and insights for all data protection questions and protocols. 

This policy can be as robust or simple as your organization sees fit, but at a minimum, it should: 

• Outline the measures taken to protect data. 

• Outline the responsibilities of each party involved in the data collection process. 

• Include a list of data that should be protected. 

• Procedures for monitoring and responding to any potential security breaches. 

• Specify how long data will be retained and when it should be destroyed. 

Train the Entire Team on Data Protection 

Once you have your policy, it’s time to train the team. This will ensure that everyone knows the importance of data protection and knows the procedures for responding to any potential security incidents. 

For training, choose the methodology that would work best for your clinical trial stakeholders - in-person, online, video on demand, workshops. The options are endless. Choose the one that works best and then ensure that the training covers all aspects of data protection, from encryption to audit and compliance procedures. The training should also cover their data protection responsibilities.

Regularly Monitor Data Access

Limiting and auditing data access is critical to strong data protection policies. DSMBs should routinely monitor data access to ensure that only authorized personnel have access to the data. This can be done through the use of audit logs, which track and document any data access attempts. 

Third-party tools (like the Cloud Concinnity platform) can be used to provide DSMBs with a robust toolset to manage data access and monitor data compliance. To learn more about how Cloud Concinnity can help improve DSBMs data protection policies, schedule a demo here. 

Utilize Firewalls and Network Security

A mix of firewalls and other network security measures can help DSMBs keep trial data safer. Firewalls can act as a barrier between your network and the outside world, preventing unauthorized access to your data. Network security measures such as intrusion detection systems and backup data solutions can provide additional layers of protection to keep data safe.

Use Encryptions Where Needed

Encryption is one of the most essential data protection measures. Encryption scrambles data so that it is unreadable to anyone without the encryption key. This ensures that even if the data is accessed by an unauthorized party, they won’t be able to interpret and use the data.

Start by encrypting any confidential trial or patient data that you store or process. You should also consider encrypting your company’s internal communications, such as emails and instant messages. 

Implement Multi-Factor Authentication For Trial Stakeholders 

Multi-factor authentication adds an extra layer of security to your systems. By requiring multiple pieces of information to access data, you can keep critical data safe in the event of a stolen password. 

Several multi-factor authentication options are available, including mobile security codes, authenticator codes, or even biometric data points (such as fingerprints). The best choice for your trial is one that offers security without being too much of a nuisance for your team. 

Perform Regular Security Audits

Regular security is an essential part of data protection. Regular security audits will allow your team to identify and address any potential security vulnerabilities before they become a problem. 

On top of your systems, you should also audit your data protection policies and procedures to identify gaps and determine efficiencies. Remember, the policies are there to serve the clinical trial and the DSMB. If they aren’t working, don’t be afraid to make a change. 

By implementing these data protection tips, data safety and monitoring boards can ensure that the data they are responsible for is secure and private. If your DSMB is searching for new methods to improve data protection, we can help. We built the Cloud Concinnity platform to help DSMBs protect their clinical trial data.

Pro Tip: With the Cloud Concinnity platform you can implement a workflow to automate the above - eliminating manual audits and ensuring security compliance. Learn more and schedule your demo of the Cloud Concinnity platform here. 

6 Tips For Assessing Clinical Trial Documents and Processes Before Any Automation

Our process automation capabilities are one of the most popular features of the Cloud Concinnity platform. With just a bit of planning, your team can automate tasks that used to take hours of manual time to complete. But, before you decide how and what processes and documentation you can automate, you analyze your current manual processes. Here are six tips to guide your analysis and documentation of your current state.

How to Prepare For Automating Documents and Processes 

Identify Your Efficiency Gaps

Start your automation process by analyzing your current workflow processes and identify areas where there is room for improvement and where there is inefficiency. This will not only make the automation process smoother (as you can identify the immediate impact of automation), but also help streamline and optimize your overall workflow. 

We would also recommend involving team members in this process for their insights and suggestions on potential efficiency gaps. By addressing these issues beforehand, you can set yourself up for success with automation and ultimately improve productivity and performance within your organization.

Understand Which Processes or Documents Will Benefit Most from Automation

As you identify inefficiencies and correlate impact, it'll become clear which processes and documentation would benefit the most from implementing automation. Let this insight help to establish your priority roadmap. 

At the same time, starting to put a monetary value on these automation (in terms of reduced errors or labor hours saved) can help determine a budget that would make fiscal sense to support these automatons. 

Take Into Account The Needed Complexities

Not all workflows are created equal. Some take minutes to set up, while others may involve more time and energy to get set up. It is crucial to consider the needed complexities when setting up a new project or task. This will ensure that all steps and processes are adequately accounted for, preventing potential roadblocks or setbacks in the future. 

Additionally, considering the complexities can lead to more efficient and streamlined workflows, ultimately saving time and resources. So before diving headfirst into a new project or task, take a moment to assess any possible complexities and plan accordingly. Your future self will thank you.

Organize Your Critical Information

One of the benefits of automating processes is streamlining and organizing critical information. However, to successfully do this, it is critical to clearly understand what information is necessary for your processes and how it should be stored. 

1. First, identify the key pieces of information needed for each process. This could include patient and protocol  data, project details, deadlines, etc.. 

2. Next, determine the best method for storing this information. This could mean using a designated software program or physical filing system. 

3. Finally, consistently update and maintain this system to ensure all necessary information is easily accessible and up-to-date. 

By properly organizing your critical information, you can improve efficiency in your automated processes and ensure your data's accuracy and security.

Test. Test. And Test.

Pro-tip, don't publish your automations and then walk away. Automated workflows can quickly become outdated if a software update changes how it functions, or a small mistake in the initial setup can cause major errors down the road. You need to continually test and optimize your automation to ensure they are completed as intended. 

Regular testing also allows you to catch and fix any small hiccups before they turn into bigger problems. Plus, testing gives you the opportunity to review your automation and see if there are any additional enhancements or improvements that can be made.

In short, regular testing of your automation helps to ensure its success and effectiveness in helping streamline your clinical trial processes and documents. So don't skip this crucial step – test those automations!

Use The Right Tool For the Right Job

Using the right tool for the right job in automation can save time, effort, and money. For example, using a screwdriver to hammer a nail may work temporarily, but it is not the most efficient or effective method. 

The same concept applies to automation tools. Using a tool that is not suited for the task at hand can lead to errors and delays in completing the task. On the other hand, using the appropriate tool can increase productivity and improve accuracy. In addition, using the correct tool can also reduce strain on equipment and potentially prevent damage.  

We built Cloud Concinnity to support the specific clinical trial needs of Sponsors, CROs and oversight committee members (DMCs, DSMBs Safety Review Committees, etc.) This includes support for best-in-class automation. Using our suite of purpose-built automated workflows, your teams can confidently eliminate labor-intense interactions and documentation while reducing the risk of errors, delays, or noncompliance. 

A Case For Automation

Automation in clinical trials can improve efficiency and accuracy, leading to more reliable data and quicker trial completion. It can also reduce human error and save time and resources. Implementing automation technologies can streamline data collection, analysis, and reporting processes, allowing for smoother trial operations.

Additionally, automation can help ensure compliance with regulatory guidelines and reduce the risk of noncompliance issues. Overall, incorporating automation into clinical trials can lead to more successful and timely results.
To learn more about Cloud Connity's automation capabilities, click here to schedule a demo.

5 Ways To Streamline Virtual Trial Management With The Right Tech Stack

As the world becomes increasingly reliant on technology, it is no surprise that the clinical trial field is following suit. Virtual trials, also known as remote or decentralized clinical trials, involve using technology to collect data and monitor patient health remotely instead of in a traditional brick-and-mortar clinic setting. Successful virtual trials are built on a technology stack that meets the critical needs of virtual trials. This blog post outlines five essential technical requirements that your tech stack must support to drive successful virtual trial completion. 

The Advantages and Risks of Virtual Trials

While virtual trials have been around for several years, their use has significantly increased during the COVID-19 pandemic. With social distancing measures in place and concerns about exposing vulnerable patients to potential viruses, many pharmaceutical companies have turned to virtual trials as a safer alternative. 

Not only do virtual trials offer a solution to current crises, but they also bring with them several advantages. These include increased diversity in trial participants, reduced costs, faster recruitment and data collection, and improved patient compliance and satisfaction. 

However, virtual trials do come with some challenges. These include the potential for technical issues or data inaccuracies, difficulties in monitoring adherence to trial protocols, and a lack of hands-on interaction between researchers and participants. 

Despite these hurdles, it is clear that virtual trials are here to stay. As technology advances and more companies turn to remote options, we can expect to see even greater use of virtual trials in the future.

5 Ways to Use Technology to Streamline Your Virtual Trial

Virtual Oversight and Monitoring

Virtual clinical trials require efficient and secure methods for remote site oversight and monitoring. This includes virtual visits, remote source data verification, and virtual document management. 

When building your virtual trial tech stack, it’s critical that you include a system that can manage each of these core needs. As a best practice, ensure you choose a system that is:

• Easy-to-use.

• Effective at meeting your core oversight and monitoring needs.

• Bug-free (or as close as you can get). 

Virtual Patient Recruitment, Treatment, and Monitoring

Your virtual trial tech stack must provide a platform for virtual patient recruitment, treatment, monitoring, and adherence. This includes online questionnaires, eConsent forms, remote data collection, and virtual appointment scheduling. 

One key aspect is having a platform that allows for accessible communication and information sharing between patients, healthcare providers, and researchers. This can involve video conferencing capabilities, secure messaging systems, and electronic data transfer. 

Additionally, a robust remote monitoring system is crucial for properly tracking and documenting patient progress without in-person visits. This may involve wearable devices or mobile apps for self-reporting symptoms and collecting other health metrics. 

Virtual & Asynchronous Oversight Ops, from Safety Programs and Committees to DSMBs

Virtual clinical trials require virtual and asynchronous oversight operations, including virtual safety programs and committees and remote Data Safety Monitoring Board (DSMB) meetings. 

Your tech stack should support these functions through: 

• Streamlined Communication.

• Process Automation and Review. 

• Secure Data Sharing Capabilities.

Additionally, it is crucial to have a solid plan for training all team members on using the selected technology. This will ensure smooth implementation and efficient virtual operations during the clinical trial. Ultimately, investing in the right technology for virtual and asynchronous oversight operations can make all the difference.

Easier & Greater Access to & for KOLs

We’ve written before about the critical impact that Key Opinion Leaders (KOLS) can have on your trail. You can read more about our tips on attracting and retaining KOLs.

The important thing to keep in mind when it comes to supporting your KOLs is that your tech stack can either be a benefit or a liability. Your virtual trial tech stack should help to reduce the friction experienced by KOLs in virtual trials. 

Some examples of friction reduction include:

• Using collaborative scheduling to streamline meeting schedules. 

• Eliminate an overuse or overreliance on paperwork.

• Support asynchronous communication. 

Real-time Study Metrics & Performance Reporting

Finally, your virtual trial tech stack should include real-time study metrics and performance reporting tools. This allows sponsors to identify any potential issues or roadblocks quickly, and take immediate action to address them. It also helps ensure that data is consistently and accurately captured, meeting regulatory compliance requirements.

Consider implementing an eSource system for the electronic collection of subject data at the point of care and a centralized data management platform to aggregate and analyze this information. This type of technology allows for more efficient virtual monitoring visits, where remote reviewers can easily access all necessary study data in one place.

You can drive successful remote clinical trials by ensuring that your virtual trial tech stack meets these five essential needs. If you’re looking for a jump-start for your virtual trial management, consider Cloud Concinnity. 

The Cloud Concinnity platform was built to meet the specific clinical trial management needs of CROs,Sponsors and oversight committee members (DSMBs, DMCs, SRCs, etc). Our cloud-based systems provide vested trial parties with a centralized communication, collaboration, and data management tool. 

Learn more about how Cloud Concinnity can help drive success for your virtual trial. Schedule a demo today and get started.

Decentralized Trial Readiness: Is Your CRO Prepared for the Future?

Over the past several years, decentralized trials have become more common (due to both the pandemic and improvements in support technologies). This trend isn’t going away anytime soon. However, while the landscape is continuing to shift in favor of DCT, a new survey from Florence Healthcare has found that many CROs don’t currently have the technology to accommodate this shift. 

Three Criteria for High-Performing Decentralized Trial Technology 

System Ease-of-Use

One straightforward takeaway from this research: Sites expect the trial sponsors to supply them with the technology and tools they need to complete the decentralized trial. This includes everything from patient recruitment and engagement, to data collection and  analysis, to safety and compliance oversight. And it’s not just the tech itself that needs to be user-friendly. The entire system should be designed with ease of use in mind – for both sites and patients.

While hands-on experimentation is critical to determining a system’s ease of use, there are a couple of standard functions and design aesthetics that you can look for when evaluating a system’s user-friendliness during a demo or trial:

• The application lives on the cloud. 

• Function and navigation are intuitively designed. 

• Urgent tasks and critical pieces of new information are easy to find.

The easier your technology’s ease of use, the more likely you are to ensure adoption from your trial sites. 

Data Security & Privacy

With decentralized trials comes an increased need for data security and privacy. After all, decentralized trials are spread across multiple locations by definition, and, as such, so is the data they collect. This makes it even more critical for CROs to come into any decentralized trial with a secure, centralized platform for data collection and management.

To be prepared for the growing future of decentralized trials, be sure your CRO’s technologies include the following:

• Role-based and individual access permission settings.

• Platform and system integrations to help mitigate data leakage or loss.

• Comprehensive security features (including 2FA).

Flexibility & Scalability

Finally, it’s vital to ensure your CRO is equipped with software that is both flexible and scalable. The right tool should help to improve your CRO’s speed, efficiency, and efficacy of your decentralized trial. 

We built The Cloud Concinnity platform to provide CROs with a platform they can use to create stronger partnerships. With Cloud Concinnity, your team can more easily:

• Communicate & collaborate seamlessly with DCT sponsors and committees.

• Standardize and provide communications/reports to executive and sponsor management. 

• Replace labor-intensive manual processes with new automated workflows.

The Future of Decentralized Trials

There’s no doubt about it: decentralized trials are here to stay. Decentralized clinical trials have the potential to revolutionize the way clinical trials are conducted. By providing personalized care and collecting data more efficiently, they can help bring new treatments to patients faster and improve the overall efficiency of the clinical trial process. And while they come with some unique challenges, the benefits far outweigh the drawbacks. Ensure your CRO is prepared to capitalize on this new tomorrow by investing in scalable, robust, secure technologies that can empower your sites and improve your partnerships. 

Want to learn more about how Cloud Concinnity can empower your CRO for the future? Schedule your platform demo today. 

5 Best Practices to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials

The clinical trial field is changing rapidly. Some of these changes have been spurred by the pandemic, while others have been in the works for several years as technologies and trial needs evolve. One of the most recent changes is the rise in hybrid and decentralized clinical trials. In this blog post, we summarize five tools and tips that can help the best practices you need to support clinical trial oversight across a hybrid decentralized clinical trial.

5 Tips and Tools to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials 

As you may be aware, hybrid and decentralized clinical trials allow researchers to successfully conclude a clinical trial while conducting it partially or primarily remotely. What you may not know is that a recent EY-Parthenon survey found that respondents estimate that 50% of clinical trials will be hybrid or decentralized by 2024. While hybrid or decentralized clinical trials bring with them a host of benefits, they do introduce new difficulties based on their differences from traditional clinical trials. 

Here are five best practices to keep in mind to help mitigate these differences and enhance the benefits of hybrid and decentralized clinical trials:

1. Centralize Your Data Collection 

2. Segregate Blinded Vs. Unblinded Data

3. Communication is The Key to Success

4. Use Software To Automate Meeting Scheduling

5. Standardize Your Reporting

Centralize Your Data Collection

Hybrid or decentralized clinical trials aren’t perfect, and their most decisive benefit – the remote aspects that benefit the patients and the researchers –requires thoughtfulness and preparation to empower your team to collect and store critical clinical data.

As a starting point, we recommend selecting a centralized data collection tool that includes:

• A cloud-based system that can be accessed from each location. 

• Strong security measures to ensure that only authorized.

• An intuitive user experience that promotes adoption across all of your clinical sites. 

If you’re on the hunt for just such a system, The Cloud Concinnity Platforms has you covered. This tool was built specifically for clinical trial oversight committees and integrates with your trial’s electronic data communication platform to help centralize and systemize your data. You can learn more and sign up for a demo here.

Automate Blinded Vs. Unblinded Data Segregation

As your clinical trial is taking place across a hybrid or decentralized landscape, it’s critical to introduce automation to help you manage the segregation of blinded and unblinded data. Not only does automating data segregation replace the work that goes into the manual management of sharing blinded/unblinded data with stakeholders and participants, but it also helps to mitigate any risks that can come from manual data sharing and reporting. 

Communication Is the Key to Success

Since your research team will be communicating remotely - across cities and even time zones - strong communication guidance is a necessity for success. Given the remote aspects of hybrid decentralized clinical trials, you should anticipate higher levels of asynchronous communication – note review, comments, emails, etc. We recommend utilizing a system like Cloud Concinnity to help support these needs.

Use Software To Automate Meeting Scheduling

A key challenge for managing hybrid and decentralized trials is that your administrative team is disconnected across locations, which means getting meetings scheduled can be a bit of a pain. There’s countless back and forth, which can introduce costly delays. Instead, we recommend using available tools (like Cloud Concinnity) to automate meeting scheduling and remove the friction that comes with manually scheduling meetings. 

Standardize and Batch Your Reporting

By now, you should be aware of the benefits of centralizing your data and using automation to help eliminate some of the friction that can come from hybrid or decentralized clinical trials. Work with your team to standardize the reporting that you deliver to the clinical trial oversight committee, then use a system (like Cloud Concinnity) to automate and batch report creation. 
To best implement your next hybrid or decentralized clinical trial, you’ll need software like Cloud Concinnity, which offers remote data collection all in one place, along with the ability to communicate efficiently and virtually.

For a free demo, please reach out to us today. We’re here to help.