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As Business2Community points out, using outdated software can cause a range of major problems, risking data loss through software failure, exposing your work to software bugs or cybercriminals, and leaving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.
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.
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
Cloud Concinnity® is the turnkey software solution for end to end Board Management. Importantly for today’s environment, it was designed for creating, supporting, and implementing every aspect of board meetings online. Unlike any other solution, we had that in mind for you from day one. One shared hub, one shared goal.
We’ve seen a deluge of “expert” articles from consulting companies and established firms quickly adjusting to remote work. In my experience, these new-comers are the last people you should be listening to as they are making the same mistakes that companies who’ve done this for years can tell you to avoid. At TCC we are moving from 80% remote to 100%, so we’ve had a great head start and are happy to give you some practical advice.
Cloud Concinnity® is the only comprehensive virtual mission control available that is designed around everything that top of house leadership needs. Better board management and GRC software is the answer. We are offering RAPID ONBOARDING for your board and senior leadership teams along with reduced onboarding fees. It’s Time To Turn On Your Leadership’s Virtual Mission Control. Email or call to get started.
