Adjudicating Safety Events Retrospectively for a Completed Medical Device Trial

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.