Adverse event adjudication is a critical process in medical device trials, ensuring unbiased, clinically meaningful assessments of safety profiles. When faced with a tight timeline and a deficiency letter from the FDA, how did the sponsor of a completed large orthopedic medical device trial efficiently handle the adjudication of 370 safety events? By partnering with the MedTech experts.
This case study explores how Avania swiftly organized a Clinical Events Committee (CEC), reviewed safety events, and closed out the trial to the sponsor’s satisfaction.
Download it now to learn:
- The background and challenges of a long-term orthopedic trial
- The tight deadlines and the need for an expert CEC team
- Avania’s strategic approach to meeting FDA requirements and ensuring accuracy
- The impressive results achieved, including FDA approval for the PMA supplement
When you need efficient processes and tailored expertise for your medical device trial, It Takes Avania.