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  • preparing files submitted to regulatory authorities and Ethics Committees in support of a request to authorize a biomedical study in humans (or animals),
  • developing national master or site-specific versions of documentation given to study subjects,
  • validation of tools used to quantify Patient Reported Outcomes and Quality of Life measures
  • preparing Investigators' Site Files and Trial Master Files,
  • developing study-specific forms, depending on the specific study design and objectives,
  • help in site selection/qualification and initiation visits
  • medical writing of clinical study protocols, Investigator's Brochures, safety summaries or case narratives/listings
  • recommendation on any outstanding deficiencies and implementation of corrective action to bring a regulatory approval forward
  • processing any correspondence with Ethics Committees, including their composition and policies
  • oral translations at Investigator Meetings