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