NAMSA provides expert support for clinical events committees (CECs) and data monitoring committees and data safety / monitoring committees (DMCs/DSMBs). For many medical device manufacturers, managing the administrative details and workload of these functions is highly burdensome. We lighten your load by establishing and managing these committees on your behalf and with sponsors.
NAMSA follows a well-characterized process for documenting and reporting adverse events (AEs) that occur during investigational studies. It is designed to ensure that the AEs are reported using uniform guidelines and in compliance with applicable regulatory requirements.
Common CEC/DMC Tasks
- Developing committee charter and procedures
- Interviewing and recruiting committee members
- Negotiating agreements and remuneration with committee members
- Preparing documents such as source documentation, adjudication forms, and event narratives
- Scheduling meeting location and dates
- Facilitating meetings
- Recording meeting minutes
- Writing and distributing follow-up reports
In 2011 alone, NAMSA supported six manufacturers with their data safety reporting needs.