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.
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.
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.
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.
Smarter software and innovative approaches to the impact of COVID-19 does not stop with optimized processes and market advantages. COVID-19 is also impacting the regulatory and compliance environments of every industry.
We need innovative ways for oversight committees to stay updated personally and as a group on these changes. And, we need innovative ways for remote oversight teams to quickly get on the same page about how study protocols and other procedures and requirements for final documents are changing. All of this is best accomplished with smart technology.
The future of clinical trial oversight will be driven by innovation driven and digital transformation. will drive the future of clinical trial oversight -- it’s the only way to stay on top of the ongoing impact of COVID-19.
How is your team jumpstarting oversight innovation in your ecosystem?
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Cloud Concinnity can support your clinical trial oversight
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.
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.
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.
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.
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.
While geography once served as a limiting factor for finding mission-aligned oversight team members, cloud technology enables finding and engaging the optimal clinical trial oversight talent. And finding meaning in work is no longer a “nice to have”. It can be a driving factor in how oversight teams are put together. This will go a long way toward aligning everyone involved around a shared purpose, supporting the speed and scale aspects of new drug development.
As McKinsey has pointed out, some priorities will rise above the rest as we move into a new reality beyond the pandemic. These same priorities can focus and drive the post-pandemic priorities for every stakeholder in clinical trial oversight.
Are you ready?
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Cloud Concinnity can support your clinical trial oversight.
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?
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 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.
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?
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.
Here are 5 signs to look for.
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.
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.
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.
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.
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.
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.
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.
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.
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. Today, we explore 5 ways that smart DMC software will power the emerging future of clinical trial oversight for data monitoring committees.
This year, COVID-19 has deeply disrupted almost every aspect of governance and oversight, across industries. The pandemic changed how we work and live, and it has also changed how we think about and plan for the future. Now, more than ever, the important work of boards and special committees requires agile, adaptive tools that can facilitate access, process, and outcomes under any circumstances. Today, we explore 5 ways that smarter GRC software will power the future of governance.
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? Some were ready for 2020, some were not. Those who were understood the imperative to think and invest differently.
It’s a new normal for the business world. We need systemic, long-term change for high level business leadership. Here’s 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.
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.
3) Certainty & Security, not crossed fingers. 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.
As the COVID-19 crisis upends business norms, we all must adapt. This new normal requires fast, effective decisions to be made by teams that are forced to do their work while far apart. When the only way to connect is digitally, we must do so intentionally and efficiently. Here are three questions leaders must ask now to lead successfully during quarantine.
Video conferencing programs might be fine for your book club or your virtual cocktails, but they are inadequate to handle the complexities of board and GRC management level engagement. Cobbling together video conferencing with other apps to fill in the capability gaps introduces risk, confusion, cost and delays into the whole process. The time for a full-featured software platform that puts power and speed in the hands of your leadership is here. We understand your problem. We have incredible software to solve it. We make getting up and and running a piece of cake. Here’s why a central, secure hub for your virtual meeting, information sharing, communications and outcomes tracking is a must-have. And why it requires less time, trouble and cost than you think.
The future of your business depends on mastering virtual meetings. Step one is choosing smart software. Step two is managing the people and process elements of meetings. It’s not about “making it work” or “keeping up.” It’s about leveraging the virtual world to lead and govern even better. Here’s how.
