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.
 


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

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

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?

3 Ways Smart Technology Improves Multi-site 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 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 Clinical Trial Oversight Software? Here's What To Look For

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?

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. 

Why Data Monitoring Committees are the Unsung Heroes of 2020

Why Data Monitoring Committees are the Unsung Heroes of 2020

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.

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

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. Today, we explore 5 ways that smart DMC software will power the emerging future of clinical trial oversight for data monitoring committees.

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

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

What If We Had Been Ready?

What If We Had Been Ready?

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.

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

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

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.

5 Reasons Video Conferencing Apps Can’t Solve Your Virtual Meeting Needs

5 Reasons Video Conferencing Apps Can’t Solve Your Virtual Meeting Needs

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.

A Message from the Concinnity Company

Leading in the Time of COVID-19 & Economic Crisis

The impact of the Coronavirus (COVID-19) has been swift and severe. The actions necessary to slow the spread of the disease bring with them devastating economic consequences. 

Businesses are closing and business spending will drop. The consumer, who accounts for 70% of GDP in the US, has been sent home to face a future unlikely to make them spend while at home. A recession is just the beginning of what we can expect.

The kind of widespread disease we will likely experience is unlike anything that has hit most of the world since the Spanish Flu in 1918. Most economists now forecast unemployment north of 20% in the US, something not seen since 1929. A US deficit north of $3 trillion will be necessary for the country to win a war against an enemy that can’t bee seen. 

All of this is forcing businesses to adapt overnight, almost every night. What seemed unthinkable yesterday, seems like magically optimistic thinking today. 

There has never been a more important time for those at the top of the house to lead well.

I now spend much of my day gathering information and intelligence, including from investors, boards and trusted advisors in a variety of industries, venture and finance, learning and advising on companies’ responses to the challenges ahead. It is clear that yesterday’s plan is insufficient to position our companies to withstand what lies ahead. Many companies have realized overnight their need for an efficient way for the top of house leadership to communicate, align, and execute mission critical operations and oversight completely remotely.

Cloud Concinnity® was created to empower top of house leaders with smarter software, and that mission feels especially important right now. Our mission hasn’t changed. Cloud Concinnity® was built for times like these.

Why We Need Smart Software for Corporate Crisis Management, Strategy, Planning, Execution and Communications

Just a few months ago, no one could have foreseen the massive impact the coronavirus would have on the world. But for Concinnity’s years in the making, we saw a pressing need for smarter software for the top of the house to navigate whatever the future throws at it. We knew world class service would have to be a part of the solution. Our team and our software are here to serve.

Our customer success team takes calls from home on the weekend. Our development team is committed to maintaining the 24/7 uptime we have maintained since our launch. Our staff was already remote-work-capable, so our transition into remote work during social distancing has been seamless. 

This is a time to execute flawlessly like no other. Technology can keep us connected around tasks and to-do lists, and it can also keep us connected around our mission and values. It can make conversation and forward-thinking possible, especially in times of crisis. It can streamline processes when our teams and our thoughts are scattered, and it can provide clarity and transparency when the world is uncertain. In short, smart software helps make space for our best thinking during times of crisis. 

It is also a time to align. Our founding team has 100+ years of combined top of house leadership experience. We’ve built businesses, led companies, sat on boards, and navigated good times and bad from boardrooms and war rooms around the world. We know what it takes to lead during a crisis, and we built software that can deliver under pressure.  We offer our thought leadership, in addition to our transformative software, to assist you in the challenges ahead. Know that we are here for you. Call us and let us know how. 

Our countries and our economies will endure this crisis and come out changed on the other side. One big change we see is that top of house leadership teams will understand the need for strong, streamlined, integrated, cloud based communication — not just in a crisis but at all times. 

Stay safe, wash your hands, keep distances and make room to look ahead. 

Yours in concinnity,

Nancy Falls

Click here to access our Corporate Crisis Management Resources