Services: Post-Approval

When you partner with PPD for post-approval, you get a wealth of strategic expertise and experience in late stage development.  Our clinical experience in product development ensures collaboration and integration from pre-approval into post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet your local regulatory requirements.

PPD delivers cost-effective solutions for your late-stage study objectives. Our operational model is based on a robust technology platform to support remote centralized management of your sites, with operating procedures designed for a post-approval setting. 

Early Post-Approval Planning
Let PPD help you protect your investment with early post-approval planning.

Late Stage Research and Project Management
Our project managers provide quality deliverables on-time and on-cost, resulting in effective post-approval programs, including Phase IV trials.

Clinical Monitoring
Experienced clinical monitoring teams deliver quality, timely results. PPD provides consistent, effective interaction with study sites during Phase IV trials and other late stage studies.

Data Management
Centralized design and control of each project-specific database ensure complete integration with your requirements and systems. Close communication throughout development results in a high-quality deliverable.

Biostatistics
Accurate statistical analysis, reporting and high-quality output are delivered on time and within budget.

Safety and Pharmacovigilance
Medical and safety services are delivered via comprehensive, customized safety plans, real-time monitoring and expedited reporting.

Regulatory Affairs
PPD ensures your project progresses through all stages of drug development by guiding you through the complexities of regulatory affairs with effective assessment and strategies.

Health Outcomes and Epidemiology
With expertise in patient impact studies, PPD utilizes the most current scientific methods to assess outcomes.

Medical Information and Professional Contact Center
Choose from a full range of medical information services to support post-approval communication and research programs from a professional contact center staffed by healthcare professionals.

Technology Services
Appropriate and effective technologies augment proven product development processes.