Safety and Pharmacovigilance

PPD provides a comprehensive array of safety and pharmacovigilance services to:

• Effectively analyze potential safety issues from a variety of sources
• Efficiently process reports
• Enable thorough client review in advance of regulatory submission

Our product safety and pharmacovigilance group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing. The team has extensive experience in the collection of safety information for more than 100 products, covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices.

Individual Case Safety Reports (ICSRs)
Prepares regulatory-ready ICSRs for commercialized products, ensuring full compliance with client-approved operating procedures from initial event capture to submission-ready regulatory forms.

Aggregate Safety Reports
Assists pharmaceutical and biotech companies in preparing periodic reports, including country-specific reports.

Scientific Literature Surveillance
Creates customized solutions for unique literature surveillance requirements.

Safety Signal Detection
Utilizes signal detection and data mining software, and databases supportive of drug safety research.

Epidemiology Consultation
Oversees the development of study design, data collection and analysis plans, and prepares final reports summarizing study results.

Risk Management
Develops post-approval strategies and provides pharamcovigilance planning services, including development of safety specifications and risk minimization plans.

Regulatory Consultation
Provides effective regulatory assessment and strategy for product development, including regulatory filings and other consultative services (e.g., post-approval commitments, new drug application strategies and regulatory agency advisory committee meetings).