BEFORE THE STUDY

• 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