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.
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