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