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?

Click here to learn more about how
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? 

Learn more about how
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. 

4 Critical Considerations for Clinical Trial Oversight

Researchers, sponsors, and CRO’s know that the time to think deeply about clinical trial oversight is before a trial starts, not after. We need only glance at the recent headlines about DSMBs to see how important it is to stay ahead of the curve. 

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 age where digitally enabled productivity gains are accelerating the fourth industrial revolution across industries, it means identifying and making critical changes. 

Here are the 4 critical considerations for your clinical trial oversight team to discuss today.

1. SHARED EXPECTATIONS & NORMS DRIVE CLINICAL TRIAL OVERSIGHT SUCCESS

Communication expectations and norms must be set for the DSMB and other stakeholders before the study begins. Especially in the emerging post-pandemic world where the rules are being rewritten for everyone, clear expectations are paramount.

This means getting involved, from the top and from the beginning, with how DSMB teams are interacting. Beyond the required protocols, is everyone who needs to be communicating already communicating? As the sands shift beneath our very feet, we all need to align around resetting norms.

2. SOFTWARE TRAINING & SUPPORT MUST UNDERSTAND CLINICAL TRIAL OVERSIGHT

As a smart software company, we believe in the power of technology. And because we know that shifting habits is hard, we believe even more in robust support and training. 

Researchers, sponsors, and CRO’s must ask: Does everyone on the DSMB know how to use the software? Have all support staff and experts been properly onboarded and trained? Does everyone know who to call if there is a software question? When shifting the habits and processes, ongoing support and training are critical. Make sure it’s set up in advance for your team.

3. PUT THE DIGITAL TRANSFORMATION ODDS IN YOUR FAVOR FOR REAL CLINICAL TRIAL OVERSIGHT

Boston Consulting Group has found that the majority of companies attempting a digital transformation fail. So what does this mean for the clinical trial oversight ecosystem? It means that the odds are stacked against us all -- unless we make educated changes. BCG has also identified the key factors for flipping the odds of digital transformation success in your favor, and they all deal with having a clear strategy that starts from the top, stays agile, and involves measuring and monitoring along the way. 

In the complex clinical trial oversight ecosystem, setting the right tone from sponsors, researchers, and CRO’s is critical, and that starts with the earliest conversations about the next study.

4. MEASURE YOUR RESULTS FOR BETTER CLINICAL TRIAL OVERSIGHT

To improve, we must measure. We all know this, yet it remains difficult to put into action. This simple paradox makes the necessity of ongoing and targeted outcome measurement absolutely critical for improving clinical trial oversight. 

The good news is that implementing a single, secure smart software hub will do both. It puts processes and protocols in place that will support better outcomes, and it implements automated measurement of outcomes that will make it easy to show just how much your DSMB is contributing to improved outcomes, from improved clarity of communication to rapid efficiency of creating reports and sharing data. 

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The time has already arrived for improved clinical trial oversight. The question is not whether it is possible, but whether you are ready to step into the critical considerations that will make the future of the clinical trial oversight ecosystem as good as it possibly can be. 

Let’s do this.

Talk to someone today about how your team can step into
the future of clinical trial oversight.

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

The clinical trial oversight ecosystem is changing right before our eyes -- and fast. In an article titled The Next Normal Arrives: Trends That Will Define 2021—and Beyond, McKinsey calls out a range of shifts that will change the way we all do business. 

Which one should hit home for everyone involved in clinical trial oversight? 

Digitally enabled productivity gains accelerate the Fourth Industrial Revolution

We know that the fourth industrial revolution is already underway, as we are seeing the automation of business processes using modern smart technology all around us. Pair this trend with the understanding that remote work -- and especially remote committee meetings for oversight -- is here to stay, and a clear picture of a digitally enabled future for clinical trial oversight emerges.

So what does this mean for researchers, sponsors, and CRO’s?

1. CLINICAL TRIAL OVERSIGHT TREND #1: SMARTER SOFTWARE WILL DRIVE PRODUCTIVITY

Many oversight teams and committees are already using technology to some degree, and this trend will only continue. The big change? It’s that using these technologies -- especially smart software designed specifically for clinical trial oversight -- can rapidly increase the productivity of oversight teams. 

This kind of fast, relentless innovation is moving quickly for everyone. McKinsey reports that some executives are moving “20 to 25 times faster than they thought possible on things like building supply-chain redundancies, improving data security, and increasing the use of advanced technologies in operations.” Wow! This rings true based on the conversations we’re having with our expert advisory council and our clients as well. 

The time is now for researchers, sponsors, and CRO’s to have deep, meaningful conversations about how digitally enabled productivity gains are one of the imperatives of the new normal. 

2. CLINICAL TRIAL OVERSIGHT TREND #2: DATA SECURITY & INTEGRITY IS CRITICAL

As teams adopt new technology, data security and integrity is always top of mind. With new technology comes new rules and protocols all around. The amazing thing about this trend is that adopting mission-aligned smart software for clinical trial oversight will actually address productivity and data security at the same time. 

This means that adopting forward-thinking technology is part and parcel to adopting greater security. It also means that making these decisions is something that leadership needs to start thinking and talking about as part of conversations with every stakeholder involved. 

Whatever technology got clinical trial oversight this far is not necessarily equipped to help it grow into the future that is already here. The time for innovation and forward-thinking is here.

3. CLINICAL TRIAL OVERSIGHT TREND #3: NEW STUDY PROCESSES MATTER

The speed and efficacy with which the clinical trial ecosystem has developed vaccines and treatments for COVID-19 has been a marvel to watch. Clearly our clinical trial industry is able to move quickly and make incredible things happen while maintaining safety and oversight when we need these things most. McKinsey gives it to us straight: “The COVID-19 crisis has created an imperative for companies to reconfigure their operations—and an opportunity to transform them. To the extent that they do so, greater productivity will follow.”

Now the challenge is how to implement this kind of efficiency and productivity into the way all clinical trial oversight happens. How can we operate at our best every day and on every study? How can smart software support the highest and best use of the minds and efforts of our best science? How can automation and better, smarter processes help make great things happen? 

This is our task moving forward, and a critical trend shaping the next moves of the clinical trial oversight ecosystem.

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Whatever we were certain about a mere 2 years ago, it no longer holds true. Digitally enabled productivity and smarter remote work are the new normal, taking the clinical trial oversight ecosystem ever further. 

We’re ready to talk to you about the future of your clinical trial oversight.

3 Ways Smart Technology Improves Multi-site Clinical Trial Oversight

Large, multi-site trials are an important part of clinical trial research. They allow for deeper and broader research, while increasing the number of data points. Still, the scale of a multi-site clinical trial can, in turn, scale up the administrative and oversight challenges right alongside these benefits. We need only look to the Journal of Clinical Trials or industry whitepapers to see that challenges like communication, process, and data integrity are ubiquitous and ongoing. 

Today, we look at three key challenges for multi-site clinical trials, and how using smart, cloud-based technology for managing their oversight can improve effectiveness and impact.

3 Ways Smart Technology Improves Multi-site Clinical Trial Oversight

1. COMMUNICATION

 Instant, reliable communication is paramount to support quality clinical trial oversight, and this challenge is multiplied when there are multiple sites. Those at the site level are dealing with tremendous communication challenges already, and those challenges have the potential to bubble up to the oversight level. The DMC must be aware of these challenges and have tools to properly monitor the communication -- and have good tools and processes for their own internal communication. 

Indeed, the DMC needs its own robust, secure, real time platform for communication -- especially in the event of communication challenges or breakdowns outside of their control. For communication to keep up with a multi-site clinical trial, the oversight committees need a single, central, and robustly secure software hub. 

Smart software creates a channel for better communication.

2. DATA INTEGRITY

We know that for any multi-site clinical trial, there are many different software solutions managing many different things. This can be a source of challenges for the study. The Journal of Clinical Trials writes that “Researchers conducting clinical trials in multiple clinical sites with targeted populations face significant management challenges to maintain data integrity…” Oversight committees must be mindful of these challenges as they are reviewing data themselves and must ensure that the method and manner in which data is served to them maintains integrity, security and timeliness in order to safeguard patients.  

Creating a single, central hub for the oversight of data integrity provides a reliable channel for all data, whatever its source, to be checked in a standardized, formalized way. Even if patient data is being collected in different ways by different platforms and different people, it is being checked and overseen by a single, central set of people on a single, central platform. This reinforces the data integrity of every step of the clinical trial.

Data depends on a single home for efficient oversight.

3. STANDARDIZATION

Oversight standardization is equally critical. With a multi-site clinical trial, the oversight committee is dealing with the added challenge of standardizing the oversight across all sites. This can run into challenges if reporting information or processes is not standardized, or if protocols vary across sites. 

A recent whitepaper from Medidata calls out complexity of project management and collaboration as a major challenge for everyone in the clinical trial ecosystem, and added complexity means that the time and energy it takes to maintain proper oversight will increase in kind. 

The answer? Standardization of oversight processes and protocols. And while this answer may feel straightforward, it also shines a bright light on how integral a single, secure software hub can be for clinical trial oversight, especially in a complex multi-site study. 

Smart software supports smart oversight standardization.

Do your clinical trial oversight teams have the right tools for efficient, effective oversight?

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

Choosing Clinical Trial Oversight Software? Here's What To Look For

Choosing the right clinical trial oversight software is critical. We need only glance at the damaging news cycles around vaccine development to see how high the stakes are and how slim the margin of error really is for communication, security, and speed. 

But, what is clinical trial oversight software? Why is it so necessary? And what distinguishes great clinical trial oversight software from the pack? 

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE SIMPLE. 

Clinical trial oversight software needs to create less work, not more. It needs to be simple to learn, simple to use, and simple to roll out. This means a great user interface and experience, plenty of helpful documentation, and ongoing support for administrators. Simplicity also means there should be less work for the admin because of the software, and less to remember for committee members, too. Look for smart software that uses automation.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE INTEGRATED. 

In order to be a true one-stop-shop for oversight committees and administrators, clinical trial oversight software must be an enterprise grade integrated system that plays well with others. It must integrate with relevant clinical trial software that provides critical inputs to the work of the committees, such as eClinical data systems. It must also integrate with systems that rely on oversight committee information, such as eTMF software. Finally it must provide or integrate with standard productivity solutions such as document, signature, meeting and video conferencing management software. These integrations are powerful drivers of security, speed and efficiency in oversight work and communications.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE SECURE. 

When we say secure, we mean airtight security that meets the highest possible standards. Truly secure clinical trial oversight software should meet the standards of a SOC 2 certification, use the highest level of data encryption, provide intrusion detection and breach monitoring, offer 24 hour continuous monitoring, and of course have protocols like access control and two-factor authentication. Patching together productivity software plus regular email and video chat is not secure enough to manage clinical trial data or communications. Great clinical trial oversight software will reliably protect unblinded data and reduce confusion in favor of clarity every step of the way.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE FLEXIBLE AND SCALABLE. 

Finally, clinical trial oversight software must flex to fit your operations in terms of scale and process. It should not only scale as your needs grow, but it should provide the operational leverage that allows your teams to do more. It should serve two or twenty members equally well, and also enable administration of one hundred studies as efficiently it does one. Key elements to look for include easily customizable, automated workflows that empower administrators and software with a development team who are consistently innovating and adding features in response to your needs. 

Are you ready to kick your search for the best clinical trial oversight software into high gear? 

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

5 Signs Your Current DMC Software Is Outdated

Have you done a review of your DMC software lately? Has a review ever been done? Do you know who is responsible? Now is the time.

As Business2Community points out, using outdated software can cause a range of major problems, risking data loss through software failure, exposing your work to software bugs or cybercriminals, and leaving important work open to lost productivity through inefficiencies or sudden software incompatibility. The list goes on. 

We need only glance at Harvard Business Review to remind ourselves why “In the Digital Economy, Your Software is Your Competitive Advantage.” This is true across industries, and has become an urgent, necessary need for every stakeholder in the clinical trial oversight ecosystem. 

Is Your DMC Software Outdated? 

Here are 5 signs to look for. 

1. YOUR DMC SOFTWARE IS ACTUALLY MANY SOFTWARES COBBLED TOGETHER

Does your data monitoring committee use integrated software? Or, like most teams, are you patching together email, texting, video calls, and a variety of partial security measures that aren’t designed to work together? 

If your DMC software isn’t a single, secure hub, you are open to all kinds of security threats and inefficiencies.

2. YOUR DMC SOFTWARE MAKES ONBOARDING DIFFICULT

When you think about onboarding new members to your DMC, or writing a charter and starting with an entirely new data monitoring committee, how does your gut feel? Do you have that moment where you realize the new people will need to create multiple new accounts and learn new habits just to get started? 

DMC software that is all inclusive and holds everything a monitoring committee needs in one place is truly the only way to go in today’s asynchronous, remote working environment -- and it makes onboarding a snap.

3. YOUR DMC SOFTWARE IS SECURE… YOU THINK?

Who on your team can vouch 100% for the total and complete security of all data and communications related to your data monitoring committee? Not sure who? Not sure what that would even mean? 

That means your software and/or your process are dangerously outdated. It’s time to look for a comprehensive solution that is verified to the highest industry standard.

4. YOUR DMC SOFTWARE DOESN’T EXPORT THE FILES YOU NEED

It’s no secret to any DMC what files and data that sponsors, CROs, AROs, or even the FDA will need to review. So if the software your DMC is using doesn’t set everyone up for success by supporting the creation and tracking of those files, then how is it really helping you? 

Great, smart software is available and has come of age. If your software doesn’t export the files you need, it’s time to find one that does.

5. YOUR DMC SOFTWARE DOESN’T MAKE YOUR ADMIN’S LIFE EASIER

In the end, clinical trial oversight software should benefit everyone in the clinical trial ecosystem. But the DMC admin needs to love the software the team uses. If the admin isn’t saving time and seeing benefits to stakeholders every step of the way, why are you using it?

BOTTOM LINE: DMC software should deliver speed, scale and security, making everyone’s life easier. 

Ours does. 

Click here to explore why Cloud Concinnity is the best way
to update your DMC software. 

Beyond COVID: 3 New Standards for Clinical Trial Oversight

The Covid pandemic has impacted the entire clinical trial oversight ecosystem. What worked just a year or two ago will no longer get the job done. Clinical trial oversight committees need a new way to address complicated challenges like working remotely and asynchronously, and they need the right software to get things done efficiently and effectively.

It is time to be creative and innovative about how clinical trial oversight work is done so that it keeps pace with the rapid changes, pressures, and variabilities that are now part of clinical trial management.

Those who want to thrive in clinical trial oversight beyond Covid need to engage at a high level of speed, scale and security.

Here are the three new clinical trial oversight standards that we see as mandatory to thrive in the world beyond Covid -- and how we’ve already integrated these oversight standards into Cloud Concinnity so that forward-thinking teams who use our software can be sure they are prepared by default for the new normal.

The New Standards for Clinical Trial Oversight in 2021

1. FACILITATED ACCESS

Covid has changed how we communicate, and forever made instant communication the new normal. Oversight committees are expected to communicate much more often than in the past, and be able to access both data and each other anytime, anywhere.

The dynamic study ecosystem of today asks oversight committees to respond in real-time to new developments, news cycles and other stakeholder demands. Where traditional timelines saw periodic meetings to review data, the new normal demands 24/7 access and availability.

his new cadence means teams need to be more adaptive. The new nature of oversight calls for insight and innovation. We must put systems in place where all oversight committees and other key leaders can easily and securely communicate insight to sponsors and CROs. 

Cloud Concinnity does this with a single, secure hub that lives in the cloud. Wherever any committee member is, they can access data and each other as long as there is an internet connection. As an example, we prioritize secure online messaging and video chat, because that is how people work now. 

At the same time, this access must be carefully facilitated to ensure security for patient information, aggregate data, and communication records. Sponsors and CROs need easy-to-use, strict controls over who sees what data, who has access to what documents, and how information is stored. 

In short, you need facilitated access, not simply open access. That’s why Cloud Concinnity offers detailed, role-based permissions to allow deep customization. 

Click here to learn more about how Cloud Concinnity offers facilitated access.

2. CONTROLLED PROCESS

Just as Covid has changed where people work, it has also changed how people work. 

In-person meetings and a reliance on printouts are out, while online meetings and Zoom calls are in. We built Cloud Concinnity on this kind of cloud-based communication -- with the flexible and controlled process to go along with it.

The pandemic has already disrupted the entire clinical trial ecosystem, delaying or canceling almost everything. Even now, it continues to hamper, slow or stall trials for all kinds of new drugs and treatments. For any oversight committee dealing with a Covid-related drug trial, the pressure to move quickly is high. 

The only way for those trials to catch up is for the entire clinical trial oversight ecosystem to get more efficient, and the only way for that to happen is to create consistent, controlled processes that will change the way things are done. 

While some teams are dipping their toes into digitizing reports or using productivity apps, the only solution that solves the problem of how to effectively control processes is using a single, secure hub like Cloud Concinnity.

A shocking amount of time is attributable to administrative work at a time when such resources are increasingly scarce. This can be eased and minimized with smarter technology and automated processes. 

The new standard for oversight tech is to automatically track who has done what and when, making the work of admins easy, efficient and trackable. 

At the same time, committees and their work are subject to increasing scrutiny through regulatory pressure, auditing, and media attention. A platform that ensures, and documents, regulatory compliance and implements best practices is the tool of choice for those responsible for ensuring and overseeing compliance. 

Cloud Concinnity does all of this, and is built around controlled process. Automated processes mean more efficient interactions, consistent application of best practices and significantly reduced risk of delays, errors and noncompliance. 

Click here to learn more about how Cloud Concinnity supports controlled process. 

3. TRANSPARENT OUTCOMES

Finally, Covid has also changed what we all expect from each other and from our work. 

Not only do we expect quality, speed and scale from our businesses, but we expect flexibility and transparency from each other. Covid has pushed us all to become more adaptive and more creative. 

And to do that, we need reliable data to share with each other, and visibility to build insight on top of. Today’s clinical trial oversight committee members need reliable insight into what matters. 

This means a new level of transparency and accountability for all stakeholders in the clinical trial ecosystem. It means regularly updated, agreed upon performance metrics. 

And it means using software that offers a central dashboard, reliable analytics, workflow progress reports and audit-ready information all along the way.

Faster insights and faster action come from smart software that facilitates access for teams, allows admins to control processes, and wraps all of this innovation together with reliable, transparent outcomes.

Cloud Concinnity is always audit-ready and simple to export, interactions are automatically documented and available for review anytime, and everything is always up to date. 

Click here to learn more about how Cloud Concinnity delivers transparent outcomes.

IN CONCLUSION

Thriving in today’s clinical trial oversight ecosystem is not easy. But it is possible, and it starts by understanding the new standards for clinical trial oversight. 

Is your oversight committee strategy ready for the world beyond Covid?

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 stakes are simply higher now for every stakeholder involved in funding, managing and overseeing clinical trials.

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.

Taken together, these factors pose a serious threat to traditional practices of clinical trial oversight. Here are some of the old processes that are being challenged -- and how Cloud Concinnity can facilitate critical transformation.

1. ENGAGEMENT CADENCE

Clinical trial oversight historically followed a predictable, steady cadence of infrequent meetings. Certainly, there was no way for oversight committees to be in daily contact. Events that once evolved slowly now move much more quickly. Also, risks around safety and efficacy events aren’t so predictable.

Without platforms and processes in place to ensure oversight teams can communicate and engage outside the typical meeting cycle, leadership’s contribution becomes reactionary rather than proactive.

Smart, cloud-based software means that oversight committee members can stay updated and engaged anytime from anywhere. It’s the pace at which trials move, and the pace at which oversight must as well.

2. INFORMATION EXCHANGE

Many oversight committees are still relying on a multitude of sources and download points for information and documents to send information between sponsors, CROs, and oversight committees. An issue arises when such a glut of information is provided all at once, or when there is a sudden issue calling for action and comment and everyone involved needs to be on the same page right away. The predictable information asymmetry and lack of transparency will inevitably cause problems.

In short, if the committee is not regularly sharing information with each other, there can be a serious time lag for everyone to get up to speed and make important, urgent decisions that are well-informed.

We need only glance at today’s headlines to see what happens when clinical trial information is out of sync. This is the old playbook at work. An efficient method of information exchange is essential for everyone on the team to regularly share uptodate information with one another. It means all decisions can be better-informed decisions.

3. MANUAL PROCESSES

Clearly clinical trial speed and efficiency is more important than ever -- and requiring more time than ever. So why aren’t oversight committees equipped with the best task management tools to automate mission-critical processes?

While members can cobble together multiple tools for a small shot in the arm to efficiency, when they are not a single, secure hub enclosed in a protective layer of security they become more part of the problem than the solution. Automating what are typically manual processes adds a tremendous amount of value and makes the single hub a vehicle of tremendous efficiency.

4. TRANSPARENCY

Increased pressures have made it even more critical to quickly anticipate challenges and course correct accordingly. Sponsors and CROs have a responsibility to empower oversight committees to see and drive these corrections, and every stakeholder in the clinical trial process is increasingly under the microscope for its ability to do so effectively.

Without on-demand access to regularly updated data and performance metrics, stakeholders find it difficult to effectively fulfill their responsibilities. Cloud Concinnity's software is unique because it facilitates updates for all users in real time. Transparency is achieved through efficient information sharing.

5. RESISTANCE TO CHANGE

This isn’t a nuanced challenge: the fact is that many sponsors, CROs, and oversight committees are simply resistant to a new way of doing things.

With the rate of change in the clinical trial ecosystem skyrocketing, an unwillingness to keep pace puts patient health, study integrity and value creation in extreme jeopardy.

What’s more, in a competitive marketplace, it is the innovators who differentiate themselves and their market positioning, not those who are using the old playbook.

Cloud Concinnity allows stakeholders to be clear forward-thinkers and innovators in clinical trial oversight.

CONCLUSION

In today’s turbulent environment where sponsors, CROs, and the ecosystem of oversight committees are under immense pressure, the stakes are high for funding, managing and overseeing clinical trials. Old processes and playbooks must be challenged -- and changed.

Cloud Concinnity can facilitate the critical transformation and help clinical trial oversight rise to the many challenges of today.

Learn More About How Cloud Concinnity Can Improve Your Oversight

4 Critical Takeaways from AstraZeneca and its DSMB

News that a Data Safety and Monitoring Board (DSMB) overseeing AstraZeneca’s Covid-19 vaccine trial publicly challenged the company’s drug efficacy reporting has been a gut punch to the entire clinical trial ecosystem.

In a world clamoring for faster and faster vaccine development, we are seeing spectacular success in getting life saving drugs to market. We are also seeing a system pushed to its limits. Developing multiple safe, effective vaccines in under a year is incredibly impressive. Distributing hundreds of millions of doses is equally amazing. At the same time, the stress and pressure of moving quickly while also grappling with rapidly evolving communication requirements and procedural adaptations has introduced a host of new challenges at every point in the drug development process.

Critical independent trial oversight, the kind provided by DSMBs, historically progresses over months and years. That luxury of time to act, react and communicate more deliberately has disappeared.

Whatever the multiple and varied root causes of the current clinical trial crises are, they shine a bright light on what’s critical and essential in good clinical trial oversight. We are seeing in real time just how important DSMBs are. We are also seeing that communication and process norms that have worked for decades need to evolve, change, and adapt to the new normal.

Every clinical trial stakeholder who is involved in the regulatory and independent oversight committee processes, from sponsors, to CROs, to DSMBs, can seize this moment to look at communications, processes, and systems.

1. TAKE A HARD LOOK AT COMMUNICATIONS

It’s not the people. It’s the processes. It’s the systems.

The vast majority of people in the clinical trial ecosystem — researchers, sponsors and independent bodies — approach their work with high scientific and ethical standards.

Mistakes can easily happen when processes and systems for coordinating and documenting oversight are stretched too thin, or when oversight tools are decentralized. Today most DSMBs are forced to rely on processes and systems for creating transparency, communications and reporting that are fragmented inside and outside of their organizations. Administrators can find themselves at the center of rules, communications and processes that are not optimized for speed and efficiency and increase risk for non-compliance or miscommunication.

Without an integrated set of information and communication tools, it’s impossible to know the status of oversight committees or to audit effectiveness in uncovering research issues or unintentional process violations. It’s a real threat to otherwise tight clinical trial processes.

2. CONSIDER HOW STANDARDIZED PROCEDURES IMPACT TRUST & SAFETY

Standard Operating Procedures (SOPs) have a critical role to play for DSMBs and the overall process of clinical trial oversight. Whether born of the charter and study protocol, the safety plan, or other documented sources, creating and following SOPs is the road to safe, speedy trials that inspire trust.

The challenge facing DSMBs and administrators is not so much knowing or developing these operational best practices, but implementing, tracking and reporting on them. Too many studies are still relying on manual processes or using multiple software tools that aren’t designed to work together. The results of these kinds of disconnected solutions are not pretty, as we are seeing.

The depth and breadth of these challenges demand simplification, centralization and automation. What is needed is a powerful process management engine that can drive an integrated process and provide visibility into current status and historical actions.

What’s needed is smarter technology to provide a process management backbone for the independent oversight mechanisms. The future success of clinical trials is dependent on digital transformation. It’s time for the oversight part of the clinical trial system to be supported by software as powerful as the oversight committees themselves.

3. SUPPORT YOUR OVERSIGHT COMMITTEES WITH SMART SOFTWARE 

We believe in the power of smart technology to transform mission critical processes in service to a better world. Solving communication and process problems for oversight committees like DSMBs is our mission.

When we first launched Cloud Concinnity® as a governance, risk and compliance platform, it was used to solve a range of board and specialty governance management challenges. When COVID upended the world, it became the ultimate communication and process engine for DSMBs. We are passionate about helping DSMBs ensure patient safety while bringing life saving drugs to market.

Cloud ConcinnityⓇ takes the work of an oversight committee and creates repeatable best practices, then instantly reports the status of the work and provides a comprehensive audit trail.

Think of Cloud ConcinnityⓇ as an eClinical solution built on a robust, integrated, cloud based governance process management engine. It provides a single, secure hub to organize, coordinate and document the end to end activities of the DSMB.

Whatever the appropriate processes are for any trial oversight committee, here is how Cloud ConcinnityⓇ helps improve the execution, documentation and visibility of SOPs:

• SOPs for an oversight committee are broken down into tasks

• Tasks are assigned to individuals by their roles

• Execution of the tasks is tracked

• All actions within the system are logged

• Regular reporting of SOP status is visible as desired

• Comprehensive audits are available in seconds, since all work is in Cloud Concinnity

4. ACT NOW 

Today’s flurry of news is not just an urgent, pressing problem for the current round of vaccine development — it is a clarion call for every stakeholder in the clinical trial ecosystem moving forward.

Imagine the improved communications for DSMBs that begin using a single, secure cloud based hub to communicate. Imagine how clear and strong that message about the culture of respect and support for DSMBs will be sent. Imagine how sponsors can step up right now and show how fully they support their DSMBs by providing smart technology.

The problems flooding the news right now are preventable for those ready and willing to take action. Smart software solves communication problems. SOPs support safer, more trustworthy clinical trials.

We have the solution, ready to be deployed.

To learn more, explore our DMC & DSMB software.

For details, check out our Features & Benefits document.

Why Data Monitoring Committees are the Unsung Heroes of 2020

COVID-19 has made 2020 one of the most challenging years of our lives. In the face of unrelenting challenges, our healthcare ecosystem has stepped up in a major way, creating multiple vaccines in record time for a virus heretofore unknown.

What governments, researchers, clinical trial sponsors and managers have done is unprecedented. Vaccine development typically takes 10-12 years. Yet, we are seeing these vaccines come out in well under one year. While some of the factors that enabled this response were years in the making, we are are all benefitting from a herculean, cross-industry effort to mobilize resources and funding when it matters. Healthcare providers have risked their own health to test, treat, and now vaccinate us. A massive logistical infrastructure is adapting to produce and deliver millions of doses. The world is forever in all their debt.

We want to shine a light on a group of unsung heroes who have been integral and essential in developing these vaccines. Without their independent oversight, we would have no assurance of vaccine safety and efficacy. Without them, we would not have vaccines going into arms today.

We are grateful for their service and honored to support them.

What Data Monitoring Committees do & why you should care

We believe that Data Monitoring Committees are indeed unsung heroes of 2020 because they deliver the things no one else can: Trust and safety in new and innovative healthcare treatments.

DMCs are independent groups of clinical research experts, including physicians and biostatisticians, who oversee clinical trials. Their role is to monitor patient safety, data integrity, treatment efficacy and protocol adherence during a clinical trial. Importantly, they work autonomously of the people, organizations, and institutions conducting the clinical trial.

These DMCs are in place to keep patients in a drug trial safe. Responsibility for recommending that a study proceed, pause, be amended or end rests with these influential committees. If any safety issues rise up in the data along the way, the DMC members will recommend pausing or stopping. On the other hand, if superior effectiveness is clear early on, they may also end a trial early to accelerate drug availability.

DMCs also help move things along. Their work helps ensure that less time and resources are spent on trials with unpromising results, while expediting support for drugs that are are exceeding expectations to find approval and availability as quickly as ethically possible.

The work of the DMC is highly regulated and tightly prescribed. DMCs must provide documentary evidence of their activities. This documentation is a key part of regulatory approval submissions.

These little known specialty governance committees and boards are indispensable. If only people knew of them, confidence in drug safety and effectiveness, even when brought to market with incredible speed, would soar. So herewith, we shout out the DMC.

Our Passion for the work of the DMC

This year, we at the Concinnity Company have been in a unique position to watch as these little-known yet incredibly important groups of experts have shaped and protected global health.

As a cloud software company rooted in governance expertise, we saw early on how important smart software is for doing this kind of work efficiently, safely, and with total compliance and transparency.

As the world sped up and adapted in response to the coronavirus throughout the year, we adapted our specialty governance software to serve the unique needs of data monitoring committees.

We are proud to provide smart software for DMCs and support them in doing their critical work more efficiently, effectively and with reduced risk.

To learn more about how our software platform can serve your unique governance and oversight needs, click below.

5 Ways Smart DMC Software Will Power the Emerging Future of Clinical Trial Oversight

This year, COVID-19 has disrupted almost every aspect of clinical trial management and oversight. Research estimates that 80% of non-COVID-19 trials have been interrupted or stopped. The modifications to accommodate virtual and remote operations as trials resume are unlikely to be short term.

Trial managers are being encouraged to maximize all available technology to adapt. Likewise, the data monitoring committees providing oversight through all of this change, must also adapt. Streamlined processes and better tools will be imperative.

Dedicated and smart DMC software will power the emerging future of clinical trial oversight.

Chairs and Administrators need DMC software tailored to the communication, data, and security challenges of remote clinical trial oversight, and everyone on the committee needs easy-to-use, efficient tech that “just works.”

We understand these challenges, and when COVID-19 hit, we were ready. Our platform, Cloud Concinnity®, has been configured specifically for specialty DMC governance needs. It delivers global access, process management, and outcome tracking with certified security that is prepared to meet the exacting needs of this new era of clinical trial oversight.

Here’s how.

5 Ways Smart DMC Software Will Power the Emerging Future of Clinical Trial Oversight

1. Secure Document Sharing

   Cloud software is unique because all updates populate for all users in real-time. That means radically streamlined productivity, and allows DMC members to feel confident that they have 24/7 access to the emerging data, no matter where they are in the world or what time it is when they log in. Whenever any DMC member reviews data, they are reviewing the most up-to-date data available. Real time information updates and availability contribute to overall data integrity and support audit-readiness from end-to-end.

2. Simplified Scheduling

   One of the biggest challenges for DMC chairs and administrators, especially in the age of COVID-19, is managing everyone’s schedule. Smarter software eliminates countless emails and time-consuming delays by centralizing the scheduling process and automating many of the schedule alignment challenges that otherwise drag down our efficiency. In the end, it makes scheduling feel effortless for the whole DMC team.

3. Blinded vs. Unblinded Data Segregation

   Clear role-based permissions and workspace segregation mean blinded participants will never see unblinded data — it’s simply not possible. Built-in confidential data segregation replaces the time-consuming, manual management of sharing data to open and closed sessions or blinded and unblinded participants. This structurally eliminates the chances of compromising unblinded data.

4. Enrollment Data Tracking

   Because enrollment information can be easily updated across the platform a timely way, DMC members always see current enrollment data and are able to keep pace with the study as it evolves and changes. This means communication, data review, and decision-making all stay in step with the rest of the clinical trial, and nothing is lost or out of sync.

5. Automated Notifications

   Every benefit you see in this post is powerful on its own. Now add automation. Automated scheduling emails, automated meeting reminders, automated task notifications, and automated compliance documentation. With so much automation moving productivity and communication along, committees will find momentum in the mundane, and the ongoing interactions mean that when meetings happen, everyone is already up to date, making everything move that much faster.

In today’s clinical trial environment, data monitoring committees need superior DMC software.

Contact us now to learn more about how Cloud Concinnity can change things for your data monitoring committee.

How Smarter GRC Software Will Address the Emerging Digital Future of Boards and Committees

COVID-19 has deeply disrupted almost every aspect of corporate life. Boards and committees charged with governance, risk and compliance oversight have not been spared these dramatic shifts and are needing GRC Solutions. Much as the pandemic has changed how we work and live, it must also change how we think about and plan for a future decidedly more online. As global leader McKinsey & Company sees it, 2021 will be a distinctly digital year.

Now, more than ever, the important work of boards and special committees requires agile processes and cloud-based tools that can facilitate the work of these teams under any circumstances.

On the precipice of 2021, leaders must demand a cloud-based hub that delivers global access to all information, communications and activities, manages processes automatically, and simplifies outcome tracking. All with certified security that is prepared to meet the exacting needs of this new era of governance.

Here are the new table stakes for needed GRC Solutions.

How Smarter GRC Software Will Address the Emerging Digital Future of Boards and Committees

1. A Single Secure Information Hub

   In the absence of dedicated software for their work together, committees and boards have been forced to rely on cobbled together tools for document sharing, communication, reporting and activity management. The time, effort and expense to do this is massive. While necessary in a crisis, such solutions introduce significant risk over the long run. Cloud software is unique because all updates populate for all users in real-time. That means radically streamlined productivity for administrators, and allows all members to feel confident that they have 24/7 access to the emerging data, no matter where they are in the world or what time it is when they log in. Whenever any member reviews information, they are reviewing the most up-to-date data available. Having a single source of truth in terms of all information, communications and activities contributes to overall data integrity and supports reporting readiness from end-to-end.

2. Simplified Scheduling

   One of the biggest challenges for administrators, especially in an era of more frequent and unscheduled activities, is managing participant scheduling. Smarter software eliminates countless emails and time-consuming delays by centralizing the scheduling process and automating many of the schedule alignment challenges that otherwise drag down efficiency. In the end, it makes scheduling feel effortless for everyone.

3. Data Security

   Cyber risk is real. Using a collection of tools increases that risk. A robust single platform with clear role-based permissions and confidential data protocols minimizes confidential information leakage. Built-in security and data protection protocols replace the time-consuming, manual management of data sharing through unsecured connections. This dramatically reduces the chances of a data breach and minimizes the anxiety of sharing the wrong information.

4. Streamlined Decision Making

   When all information is updated across the platform in real time, members always see the most up to date information and understand next steps in real time, meaning everyone can keep pace with projects as they evolve and change. This means communication, data review, and decision-making all stay in step, and nothing is lost or out of sync.

5. Automated Notifications

   Today’s governance, risk and compliance GRC Solutions call for the smartest technology available. Process management, if not AI, should be embedded in these solutions. Features like automated scheduling of emails, automated meeting reminders, automated task notifications, and automated compliance documentation automate the routine so boards and committees can focus on the urgent and strategic. With so much automation moving productivity and communication along, committees will find momentum in the mundane, and the ongoing interactions mean that when meetings happen, everyone is already up to date, making everything move that much faster.

At Concinnity, we are motivated by making sure that boards and special committees have the smart software they need to power that future of adaptive and proactive governance.

When COVID-19 hit, we were ready. Our platform, Cloud Concinnity®, has been configured specifically for specialty governance needs, and we saw our users take advantage of those features in powerful ways.

In today’s uncertain governance environment, boards and committees need smart software. Contact us now to learn more about how Cloud Concinnity® can change things for you.

What If We Had Been Ready?

3 Pandemic Takeaways for Boards and Committees in 2021

In 2020, businesses and nations alike were thrown into the deep end.

The COVID-19 pandemic, summer protests, and the fall election season all happened on top of each other in a year of change and disruption.

How many of us were truly ready? What if we had been?

In their excellent pandemic response postmortem, Chris Tyler and Peter Gluckman argue that governments all knew that a pandemic was likely. Those caught flat footed were those who did not believe in the magnitude of the problem, were not taking the potential threats seriously, and were rewarding short-term thinking at the expense of long-term planning.

Bill Gates, among others, had been pointing to something like this since 2015. He even gave a TED Talk called “The next outbreak? We’re not ready.”

Some were ready for 2020, some were not. Those who were understood the imperative to think and invest differently.

Boards, committees and organizations that want to be ready for whatever change and disruption most certainly lie ahead, must embrace three principles.

3 Imperatives for Boards and Committees in 2021

1. Think Differently About Change

The pandemic happened suddenly — and also in slow motion. Businesses that weathered the storm well, like this list of Forbes’ top 25 corporate responders, were demonstrably agile, acting swiftly and decisively. They were people-based. They had already invested in digital infrastructure that could flex with the crisis. They had prioritized change management skills among people because they understood the need to manage long-term for continuous disruption.

And it paid off.

The kind of continuous disruption that the pandemic has brought is deep and will be ongoing, and it requires a fundamental shift in our mindset. Now is the time to embrace thinking that can flex with constant change, not a time to white-knuckle the year with one hand and cross your fingers hoping for normal with the other.

2. Operationalize Change Readiness

Planning for disruption must become a standard part of our day-to-day operations. People need tools and processes that support resilient, adaptive action-taking — and this means integrating the rhythms of remote work at all levels of organizations. Even after a vaccine, there will be no going back to how things were — there will instead be a new wave of change and disruption. Our growing pains can, and should, be the growing pains of a new preparedness.

McKinsey reports that “75% of people using digital channels for the first time indicate that they will continue to use them when things return to ‘normal.’” Adopting a new technology is never as simple as pushing a button. There is always a transition period. We need to make room for these adjustment periods, expect and prepare for them, and build resiliency and efficiency into how we adapt. People will always have to learn, and processes will always have to change. That takes time, and the failure to actively manage for these kinds of ongoing transitions impacts effective governance, efficient operations, livelihoods and even lives.

3. Invest in Robust Digital Assets

If your board or committee does not have a comprehensive digital solution, now is the time. The time for patchwork solutions is long over. We built Cloud Concinnity® in 2018 because we understood that boards and special committees needed smarter software.

When the pandemic hit, the boards and committees using our software were ready. They could immediately meet and connect, no matter where in the world they were, with 100% confidence in the security of their video calls, the integrity of all data and documents and the certainty of their processes. Whether for a corporation or a clinical trial, losing a step is never an option.

Our team has all sat on boards and special committees and advised governance leaders for decades. We know the weaknesses and the strengths of this kind of work. We built our platform to support the adaptive action that the change and disruption in the world demands from today’s boards and committees.

If you are ready to start 2021 strong with board and committee software as adaptive as you are, book a complimentary consultation with our team.

3 Secrets to Success in the New Normal for Virtual Board Communication

COVID-19 has changed everything. The shift to virtual work was happening slowly — and then all at once. 

When the pandemic hit, everyone hopped on conference calls, video conferencing, and productivity software, stretching these apps far beyond what they were built for.

We all did what we had to do to get through a sudden crisis.

No one was 100% prepared to deal with the jolt of COVID-19. 

But none of the apps people jumped onto were designed to support the kind of long-term, systemic business change that businesses need to tackle the challenges we are now facing.

If your leadership somehow had a crystal ball a year ago and could have built the perfect solution in advance, what would it look like? 

Imagine that next week, your leadership had a single sign in to communicate, share documents, manage activities and track their metrics in an elegant cloud platform.

Imagine if a month from now they could use that same app to host a virtual board meeting and all the information they had was already there. 

Imagine if everyone was seamlessly in sync when the calendar flips to 2021, rather than still scrambling to keep up with a patchwork solution. 

It’s possible. 

We are all 4 months into the reality of the pandemic, and there is no end in sight. 

It’s a new normal for the business world.

We need systemic, long-term change for high level business leadership. 

Here is what that looks like: 

1. New Systems, not quick fixes

We’re not solving one-off problems anymore — we’re solving the challenge of what work looks like in this new paradigm. Integrated cloud software is the only option large enough to handle the variety of needs any business is going to present. What we need is to reduce the number of software variables and security risks, effectively centralizing what we need to worry about — and where we need to do our worrying.

For example, software that makes video conferencing easier is good, but it’s not enough on its own. Leaders need something that holistically covers and supports everything they do — from day to day communication to document sharing. Cloud software platforms empower boards by working anytime, anywhere, and providing robust communication and storage capabilities.

2. Long Term Solutions, not short term 

No more whack-a-mole solutions. No more life preservers to stay afloat. Virtual work is here and it’s not going anywhere. 

We need software that is designed to support boards through the full cycle of board work. And that work requires a simple, central hub that gives everyone access to documents and each other, supports automated scheduling and reminder processes to keep things moving, and is equipped to track and report the outcomes everyone needs to make good decisions. 

3. Certainty & Security, not crossed fingers

Virtual board work done right makes things efficient and seamless. Done carelessly, it’s a security risk. The more texting and emailing you do, the more exposed you are to cyber risk. The more different apps you cobble together, the more chances for hacking you have to worry about. With a single, integrated software hub, you only need one wall of bulletproof security. 

We prioritize end-to-end security that allows every board member to share, chat, and browse safely and securely from any device. That’s something that cobbling together multiple solutions and crossing your fingers can’t do.

If your board needs a virtual solution built for the rigors of the new normal, we are here for you. Let us show you how you can simplify, centralize, and automate your work on a platform designed from the ground up for virtual governance. 

Click here to start a conversation with us.