Data Safety Monitoring Boards & Data Monitoring Committees
An effective Data Safety Monitoring Board, Data Monitoring Committee or Clinical End-point Committee ensures the safety of each study subject – and relies on quality data, timely communication and clinical trial integrity. In addition, DMC recommendations for study continuation, modification or termination can have a significant impact on product development.
Aptiv Solutions has the experience, resources and relationships to help you to establish the structure of your development-program-specific DMC, DSMB or CEC, identifying thought leaders and determining the type and frequency of sessions needed to meet your goals.
We maintain an extensive database of thought leaders in a broad range of indications, including past and current committee, affiliations and specialties. We can also assist in drafting DMC Charters, coordinating DMC/CEC meetings and logistics, facilitating communication with the members and ensuring the independence of the DMC/CEC.
- Collation of CEC adjudication events
- Meeting coordination/facilitation
- Writing of safety reports
- Recording of meeting minutes
- Provision of DMC recommendations to Sponsors
- Maintenance of DMC files