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Trial Management

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A well thought out and specific project management approach

The project management of early development (phase 1/2a) trials requires a well thought and specific approach. Phase 1 trials form the basis of your further development, a well-executed phase 1 trial is therefore key to the further success of your compound. As an independent CRO, specialised in early development, we are best placed to support the management of your phase 1/2 trials. Our project management team is specialised in early-phase clinical trial planning and management, including First-in-Human trials, guaranteeing you a smooth execution.

Ensuring efficient coordination and monitoring of clinical trials

We ensure efficient coordination and monitoring of clinical trials based on an integrated approach. We build a unique team of site and vendors for each project based on the requirements of the protocol or any specific needs of the compound.

Our team can assist you with:

Trial Management

  • Investigator and clinical research unit identification, qualification, and selection
  • Study protocol writing and review
  • Case report form design
  • Preparation and coordination of clinical trial applications
  • Budgeting and budget management
  • Risk management
  • Study oversight including Venn clinical trial team oversight
  • Supervision and coordination of safety management
  • Coordination of external vendors, bioanalytical laboratories and other partners
  • Set-up and coordination of dose escalation meetings or safety review committee meetings
  • Clear communication with the Sponsor
  • Sponsor Trial Master File management

Learn more about Trial Management

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