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?