Global Pharmacovigilance
Control Your Safety Management Programs with Confidence
PPD’s global pharmacovigilance group gives clients access to a dedicated team, customized to your specific project needs to help you respond to increasing regulatory pressures.
Our experienced group aids in evolving your safety monitoring and safety reporting practices in response to changing regulatory standards, allowing you to evaluate and manage risk over the lifetime of your product.
We employ more than 400 highly skilled medical and safety professionals with first-hand knowledge of regulatory requirements and therapeutic experience, providing safety coverage 24 hours per day, 7 days a week.
PPD keeps you in control of your drug safety and development programs with a robust five-tier quality program to ensure you receive the highest levels of safety services for your study. We give you access to pioneering technology and technical capabilities spanning the full range of pharmacovigilance practices.
Leverage Our Full Product Lifecycle Approach to Your Advantage
We offer a comprehensive and flexible suite of pharmacovigilance and safety monitoring services from early development support through post-approval initiatives.
Early Development Safety and Medical Services
- Program development
- Individual case safety report (ICSR) processing for serious adverse events (SAEs)
- Medical management for both clinical and safety components of product development
- Global regulatory requirement compliance and consulting
- Management of adjudication and data safety monitoring committees
- Aggregate reporting (e.g., development safety update reports)
- Medical device monitoring
- Unblinding services
Post-approval Product Support Services
- ICSR assessment, triage and processing, as well as follow-up requests
- Global regulatory reporting
- Safety evaluation and medical review
- Global literature surveillance
- Aggregate reporting (e.g., periodic safety update reports and periodic adverse drug experiences reports)
- Risk management strategies
Pioneering Technology and Tools to Keep You Involved and In Control
Our advanced pharmacovigilance technologies provide you the ability to view the status of your study in real time and to determine your level of involvement with safety monitoring and data. Through a suite of tools focused solely on collecting and evaluating safety reporting, we deliver the highest levels of quality and compliance for your programs.
- PPD EventNet ™—A global, internet-accessible electronic adjudication solution to facilitate the processing and review of endpoint safety monitoring data
- Adverse Event (AE) Capture System—Electronically captures adverse events received by the post-approval contact center and forwards them directly to our proprietary safety tracking system to ensure patient safety
- Safety Tracking System—Provides and integrates resource, case load, workflow, timeline and quality control to deliver optimal program management efficiencies
