U-TRIAL: Advancing Contract Optimization for Clinical Research

U-TRIAL is committed to strengthening the clinical trial ecosystem at UMC Utrecht, aiming to position itself as an attractive research partner for CROs and pharmaceutical companies. In clinical trials, speed is critical—both in patient inclusion and in optimizing the contract and budget processes. Currently, contract negotiations in the Netherlands take over 210 days on average, compared to 70–140 days in countries like Belgium, Denmark, and France. Clearly, there’s room for improvement.

Last year, U-TRIAL launched a project in collaboration with the Legal Affairs department and other internal stakeholders to streamline the trial contract process. Through a series of workshops, we mapped and evaluated the legal workflows, focusing on improving collaboration and efficiency in research processes.

Key Outcomes

• Centralized MasterCDA Archive
  All organization-wide Master Confidential Disclosure Agreements (MasterCDAs) are now centrally archived and accessible to stakeholders, saving time and reducing repetitive administrative tasks. Currently, 10 MasterCDAs are in place.
• NFU DCRF Template
  Adopting this template allows for faster collaboration and standardization in contract negotiations.
• Parallel Workflows
  SOP updates now enable simultaneous handling of budget negotiations and other processes, significantly reducing lead times.
• Tighten the roles and responsibilities
  Clarifying and more precisely defining the roles and responsibilities of internal stakeholders.

These improvements mark a significant step forward in optimizing clinical trial operations at UMC Utrecht. U-TRIAL: We Connect.