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FEASIBILITY

Study feasibility is a critical initial step in the conduct of any clinical trial. ELS facilitates this initial step with a well organized, systematic and detailed process. The presence of ELS Clinical Research Coordinators in every city ensures that the data collection is real time and factual.

The feasibility process includes the following:

  • Initial receipt of study synopsis from the client.
  • ELS internal review for the study specific requirements in terms of the site, patient pool, investigator experience/expertise, status of Ethics Committee, site infrastructure and other parameters.
  • Shortlisting and matching study requirements with the sites in the ELS database.
  • Scheduling appointments with shortlisted sites and investigators.
  • Personally meet the investigators and discuss the study synopsis, their interest and willingness to take up the study, patient pool, referral activities and other logistics.
  • Personally meet and/or telecon by ELS managers with investigators for discussions and clarification of queries, if any.
  • Collate and compile site responses into a Site Feasibility Grid.
  • Grade and prioritize selected sites based upon a number of factors.
  • Include study specific projections, timelines and Risk Evaluation and Mitigation Strategy.