DSBM / DMC

Setting up a DSMB / DMC
Clinrex is able to identify experts in many therapeutic fields due to well, established contacts to academic institutions and a long history in networking. A DSMB / DMC can be established with the help of Clinrex.

Writing the DSMB / DMC Charter
Clinrex can offer to write the board/committee charter according to international guidelines.

Management of DSMBs / DMCs - The Facilitator Role
The facilitator is the interface between the sponsor of a clinical trial and the board/committee. In particular the facilitator tasks include, but are not limited to:
  • Setting up an internet platform
    • Closed area (only board/committee members have access)
    • Open area (board/committee members and sponsor have access)
  • Upload data/ information as defined in the charter
  • Setting up planned or ad hoc telephone or face-to face meetings and generate meeting minutes
The facilitator limits the interaction between the sponsor and the board/committee thus ensuring and demonstrating independence of the board/committee. Regulatory authorities are very much in favor of such an approach.