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. With a strong commitment to quality, we offer:

• Clinical experience and understanding
• Creativity and dedication from our staff
• Strict attention to detail
• Clear documentation
• Consistency in all processes and procedures

PPD’s safety 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 serious adverse events (SAE), 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 technological tools

Quality Assurance

PPD is committed to performing all services in compliance with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. The medical and safety team assures quality in each client deliverable through:

• Use of a documented serious adverse event and medical management plan (SMMP)
• Scientific and safety training
• Physician consultation
• Physician review of SAEs, narratives and expedited reports to regulatory authorities
• Assignment of primary and backup physicians and pharmacovigilance staff
• Meticulous, ongoing client, safety and project team communications
• Review of selected clinical report form (CRF) pages accompanying SAE report forms
• Adherence to all relevant PPD, global and client standard operating procedures (SOPs) and working practice documents (WPDs)

Effective Technology

The medical and safety team supports scientific data evaluation with a range of effective technological tools. We ensure reliability, quality, efficiency and security, and facilitate faster communication, resulting in expedited and compliant safety reporting.

Services provided:

• Quality medical and safety coverage 24 hours a day, seven days a week, 365 days a year
• Comprehensive, customized safety plan
• Processing of 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