Every clinical study team wants to mitigate risk as much as possible, and more and more sponsors and CROs are looking for effective approaches to risk management.
While good intentions, powerful technology, and thorough training are important in the ongoing fight against risk, they won’t work by themselves. The missing ingredient in many sponsor organizations is an environment that supports cross-functional and cross-company collaboration based on honest communication and transparency.
In a recent webinar I conducted with independent clinical consultant Heather Davis, we discussed the importance of collaborative engagement—between sponsors and CROs and among teams within sponsor organizations—for truly effective risk management.
While ICH E6(R2) guidance makes it clear that sponsors own the risk associated with their clinical trials, CROs have an important role to play, too. CROs may not initiate risk assessment and mitigation plans, but they do need to support them.
Similarly, internal teams throughout the sponsor organization must understand how to contribute to the risk reduction process. ALL stakeholders must be empowered to speak up, share their unique perspectives, and make themselves available for team meetings.
Increase Your Confidence in Collaboration
In practice, collaborative risk management isn’t always easy to accomplish. While a solid 43% of our webinar attendees were happy with their level of collaboration around risk management, a significant number admitted to offloading the responsibility to a CRO (29%) or a project manager (16%), and the remaining 12% weren’t even sure if collaboration was taking place.
Figure 1. Fewer than half of webinar attendees expressed confidence
in their collaborative efforts around risk management.
To build a risk management strategy rooted in collaboration, you must have the following four components:
- Complete data integration from your data systems
Without a comprehensive picture of your data in a complex clinical trial environment, risks can remain hidden and errors are more likely to occur.
- Access to the right info at the right time
Real-time updates lead to faster action and more informed decisions.
- Actionable insights for better decision-making
Role-specific KPIs and dashboards, along with automated alerts, can empower team members to step in when needed.
- Collaborative task management tools
Collaborative task management tools make it easy to assign issues to specific team members, track actions taken, and record results—all in real time.
All of these components rely on total data transparency across study teams and vendors. A shared understanding of data leads to better communication across the board, and enables team members to resolve issues together.
With data-driven workflows in place, collaboration among study teams will improve from day one. And by collecting audit trails of data in a centralized, accessible location, every stakeholder can learn from previous issues and stick to best practices for continuously improved study performance—and reduced risk.
Watch our webinar now for more details on the benefits of collaborative RBM, including a customer success story that shows how one leading pharmaceutical company benefited from a collaborative risk management strategy across 16 studies. Key pain points that affected this sponsor’s risk profile included growing system and data complexity, declining team productivity, and failure to comply with ICH E6(R2).
If these issues resonate with you, and if you’re ready to start working more collaboratively in your organization, call Comprehend at 650-521-5449 or request a demo.