Study Start-up

Study start-up

 

Successful trials require proper planning.

Our experienced clinical team draws on our extensive database of on-the-ground investigators to offer our clients effective enrolment strategies, fast timelines and efficient site selections to ensure quick trial initiation. 

They’ll review trial documentation, and advise on any changes necessary to optimize start-up, streamline the entire process, and generally lay the groundwork for the shortest possible time to market at the lowest possible cost. A comprehensive risk mitigation strategy will be in place, to safeguard against contingencies and keep the process on course, whatever happens. 

During start-up we focus on:

  • evidence based feasibility
  • site selection
  • creation of effective risk mitigation strategies, following identification and evaluation of potential bottlenecks 
  • validation of clinical trial and regulatory documentation
  • collection and review of site regulatory documents 
  • gaining of regulatory and/or ethics committees approval
  • organization and conduct of investigator meetings