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ctive, ongoing monitoring of research subject safety is a central mandate in the protection of human subjects in clinical trials. Staffed with highly qualified medical specialists, the MedTrials product safety team provides product safety surveillance services in both the pre- and post-marketing environment. Our product safety service experience is with both pharmaceuticals and medical devices, and has been in a variety of therapeutic areas.

• Monitoring and reviewing adverse events proactively
• Providing risk-benefit analysis
• Providing information to investigative sites, sponsors, regulatory agencies, and consumers on the safe and effective use of investigational and marketed products
• Monitoring compliance with protocol and regulatory requirements for safety surveillance
• Developing standard operating procedures and surveillance plans for products monitored
• Auditing safety surveillance systems
• Developing interim and final safety reports
• Integrating safety reports into CSR and regulatory submissions