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Feasibility Studies and Site Management

Conducting clinical trial feasibility is one of the first steps in clinical trial. A thorough feasibility (An Investigator Interest Questionnaire) and site selection is the basis of any successful clinical trial. Our feasibility group has worked on virtually every therapeutic area. Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial. Our custom designed feasibility questionnaires and tested processes are effective in predicting site success in implementing a given clinical trial.

Feasibility and selection of sites

  • Maintaining Investigator database based on therapeutic area.
  • Site infrastructure to meet study specification and regulatory authority
  • Ethics committee CDSCO Registration, validity and meeting timelines
  • Investigator’s qualification, interest, experience and prior ICH-GCP trainings.
  • Availability of site staff with adequate qualification and experience (ICH-GCP trained).
  • Previous experience in similar clinical studies.
  • Trial-required facilities such as laboratories and pharmacies.
  • Trial-specific equipment e.g. measuring and imaging.
  • Site Recruitment Plan – unique for each site
  • Patient retention Plan
  • Additional sponsor requirements.