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Our services include:
  • preparing files submitted to regulatory authorities 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,
  • preparing Investigators' Site Files and Trial Master Files,
  • developing study-specific forms, depending on the specific study design and objectives,
  • 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,
  • maintaining Investigators' Site Files and Trial Master Files and providing standardized documents required before, during and after the study
  • processing all kinds of safety reports (from initial SAE narratives on a site-level to CIOMS/MedWatch notifications) on an expedited basis
  • processing amendments, informed consent updates, Investgator's Brochure updates, DSUR/PSUR updates
  • processing document packages required for endpoint adjudication
  • processing any correspondence with Ethics Committees, including their composition and policies