Medical and Safety Oversight

Our medical team consists of specialists passionate about helping improve the lives of patients around the world who are ready to provide medical and safety oversight for clinical studies:

• Medical support for protocol development and review
• Project-specific medical training (to any internal or external teams requesting it on the medical aspects of clinical research and the indication)
• Specialized support to the clinical sites and project teams by providing clarity on general protocol related questions, and medical and scientific project-related questions
• Medical expertise on patient eligibility matters
• Medical input into study reports, integrated summaries of safety, integrated summaries of efficacy, regulatory submissions and study manuscripts
• Knowledge and experience in drug and device development in all phases
• Participation in discussions with regulatory agencies
• Participation in investigator meetings
• Medical review of the data base including Adverse Events and Serious Adverse Event (SAE) to ensure data integrity
• 24/7 medical guidance to clinical sites
• 24/7 safety monitoring
• Review and approval of the medical coding (MedDRA, WHOCC)
• Processing of the individual SAEs (narrative, CIOMS writing), safety reports generation for the sponsor and assistance on SAE reports distribution
• Development of EAC (Endpoint Adjudication Committee) charter (including development of the clinical endpoint definitions and clinical endpoints adjudication forms) and coordination of the clinical endpoints adjudication process
• Development of DSMB (Data and Safety Monitoring Board) charter
• Creation and submission of DSUR (Development Safety Update Report)
• Development and review of the ICF
• Regulatory submissions of the safety issues