Tag: CEC

Data Management & Biostatistics

3 Key Takeaways on Choosing the Right Committee for Medical Device Trials

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency...

Consulting

Decoding the Distinction: DMCs, CECs, and Their Role in Medical Device Research

Data monitoring committees and clinical endpoint committees can provide independent, expert review of study data and opinions to standardize outcomes and optimize data quality to help sponsors meet complex trial monitoring requirements. As global, multi-center medical device studies become increasingly common, trial monitoring is growing more complex. Regulators require that sponsors perform site monitoring to...