Clinical Project Planning, Management and Execution

Whether you are managing your clinical studies in-house or working with a CRO, we can provide strategic planning to efficiently migrate your technology out of the IND enabling studies and through the various stages of clinical development. We also work with your team or the CRO to manage the program to ensure deadlines are met, the budget is optimized, and quality (submission ready) documents are delivered.

  • Clinical project planning, management and execution
  • Clinical programme budget planning and implementation
  • Third party contract negotiations and management
  • Vendor and site selection, qualification and management
  • Study documentation creation and management
  • Study quality systems/plans writing, set up and management
  • Auditing of study sites, in house and vendors
  • Protocol/study reports review and writing
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