Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. These expert committee assessments provide validation on clinical data as additional support for regulatory submissions and commercial strategy. What is less well understood, however, is the importance of independent expertise. Without independent expertise, sponsors risk biased decision-making, conflicts of interest, potential clinical delays and squandered resources that could otherwise be avoided.

About the Author

Lakshmi Sundar

Lakshmi Sundar is the Head of Business Transformation at WCG ACI Clinical.

Follow on Linkedin More Content by Lakshmi Sundar
Previous Video
The Role of Expert Committees: An interview with Dr. Seltzer
The Role of Expert Committees: An interview with Dr. Seltzer

What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Sci...

Next Video
A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend
A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend

New Blog: "Ask the IRB Experts"

Visit Blog