DSMB / DMC

Setting up a DSMB / DMC
Through its well-established network and long-standing contacts with academic institutions, Clinrex can identify independent experts across a wide range of therapeutic areas and support the establishment of a Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC) tailored to the needs of the clinical trial.

Development of the DSMB / DMC Charter
Clinrex can develop the DSMB/DMC Charter in accordance with applicable international guidelines and the specific requirements of the clinical trial. 

Management of DSMBs / DMCs - The Facilitator Role
The facilitator acts as the interface between the clinical trial sponsor and the DSMB/DMC. Facilitator responsibilities may include, but are not limited to:

  • Setting up and maintaining a secure online platform
    • Restricted area accessible only to DSMB/DMC members
    • Shared area accessible to DSMB/DMC members and the sponsor
  • Uploading and managing data and information as defined in the DSMB/DMC Charter
  • Organizing scheduled and ad hoc virtual or face-to-face meetings
  • Prepairing and maintaining meeting minutes and other relevant documentation

​By providing a structured interface between the sponsor and the DSMB/DMC, the facilitator helps maintain appropriate separation between the parties and supports the independence of the DSMB/DMC and the integrity of its decision-making processes. This approach also facilitates clear communication pathways and transparent documentation of DSMB/DMC activities.