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,...
Expertise: Medical Device 36 results
Medical Device
Demystifying the Differences Between DMCs and CECs
In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor...
While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed....
Medical Device
7 Questions About Clinical Evaluations for MDR
After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market...
Medical Device
CECs: What Are They and Why Does Your Trial Need One?
Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to...