Our team offers a wide range of services from DSMB Charters to DMC co-ordination in alignment with your clinical study protocol mandates.
The potential benefits and drawbacks of establishing a Data Monitoring Committee (DMC), an Endpoint Assessment/Adjudication Committee or a Clinical Trial Steering Committee are discussed during the planning of any clinical trial program, but especially those involving a life-threatening disease, adaptive designs and certain groups within the population, for example, children and older patients.
Irrespective of the type of the committee needed to support your clinical program, we can assist you by providing:
- A range of services spanning from committee charter creation to committee running and management
- PV expert membership, chairmanship, consultancy and support subject matter experts and key opinion leaders (KOLs) utilizing our PVExpert™ solution.
The added value of our experienced team in your clinical campaigns has been showcased through the:
- Development of safety management plans including outline the safety management responsibilities between PrimeVigilance and the sponsor
- Creation of pregnancy/safety guidelines and forms to ensure proper reporting of pregnancy and SAEs
- Oversight of the build and maintenance of the safety database based on the requirements of the study.