Study Start-up

Study start-up

 

Successful trials require proper planning.

Our experienced clinical team draws on our vast database of on-the-ground investigators to offer effective enrollment strategies, fast-moving timelines, and efficient site selection to get your trial moving forward as quickly as possible.

We’ll review trial documentation and advise any possible changes to streamline the process and lay the groundwork for the shortest possible time to market at the lowest possible cost. We always safeguard against contingencies with a comprehensive risk mitigation plan to keep the trial on course, regardless of unexpected events that might occur.

During start-up we focus on:

  • evidence-based feasibility
  • site selection
  • identification and evaluation of potential bottlenecks to create effective risk mitigation strategies
  • validation of clinical trial and regulatory documentation
  • collection and review of site regulatory documents
  • procurement of regulatory and/or ethics committee approvals
  • organization and conduction of investigator meetings
  • site initiation and rapid subject recruitment