Tel: 514–461–1300

Medical Oversight/ Safety Surveillance

Our medical staff consists of specialists who are available to provide medical oversight for clinical studies, including the following:
• Medical support for protocol writing
• Project-specific medical training
• Project-specific eligibility questions
• Supervision of safety monitoring and 24 hour pager coverage
• Support for medical and protocol related issues to study centers and proect team and interaction with investigators on medical/scientific issues
• Medical input into study reports, integrated summaries of safety, integrated summaries of efficacy, regulatory submissions and study manuscripts
• Participation in discussions with regulatory agencies
• Medical review of Serious Adverse Event (SAE) reports before they are communicated to the sponsor in order to assure adequate and correct reporting of these events as per ICH requirements
• 24 hour access for SAE reporting
• Cumulative and quarterly event rate and frequency tables
• Reconcile safety database and clinical database
• Processing individual SAEs and report generation
• Distribution of SAE reports
• Regulatory submissions