Planning phase

  • Design and implementation of customized quality assurance programs
  • Expectations assessment
  • Subjects recruitment strategies
  • Design et drafting of regulatory forms and reference manuals
  • Identification, qualification and recruitment of investigators and sites
  • Pre-study sites visits
  • Management of site-specific regulatory documentation
  • Preparation and conduct of site initiation visits

Conduct phase

  • Proactive subjects recruitment
  • Technical review of clinical data
  • Proactive process management of data clarification request (queries)
  • Management of deadlines
  • Management of study supplies
  • Management of investigator compensation
  • Continuous evaluation of sponsor satisfaction

Evaluation phase

  • Preparation and conduct of site close-out visits
  • General summary of services rendered and results obtained


  • Coaching and mentoring

More details will be available upon request.

Last update: 02Apr2010