Safety and Pharmacovigilance

Through our global medical and safety group, we offer global surveillance services to assist in the development of new drugs, vaccines and medical devices, as well as in all phases of clinical research.

Extensive Safety and Pharmacovigilance Services:

• Quality medical and safety coverage 24 hours a day, seven days a week, 365 days a year
• Comprehensive, customized safety plan
• Processing of serious adverse events (SAEs), including expedited report generation/submission to regulatory authorities as applicable
• Maintaining clinical safety databases, including PPD's own Web-based and electronic safety databases, as well as remote entry into the client safety database
• "Real time" monitoring and reconciliation of safety data
• Monitoring safety trends, and providing signal detection and trend analysis
• Coordination of data monitoring committees (DMCs)
• Coordination of adjudication process, including support of clinical endpoint committees

Safety and Pharmacovigilance Experience

PPD's safety and pharmacovigilance team encompasses a worldwide staff experienced in safety and clinical research. We offer:

• Dedicated, trained medical and safety staff with an expansive range of therapeutic backgrounds
• Experience in SAEs, with more than 30,000 SAEs processed since 1998 while in compliance with regulatory and local requirements
• Integrated services with other PPD departments or as customized stand-alone services
• A collaborative environment, whether working with clients, other PPD departments or third parties
• Access to a range of state-of-the-art technical tools