Post-Approval Services

 

The new era of risk management requires the ability to rapidly identify safety signals from all sources. PPD brings extensive experience in the nuances of post-approval studies, combined with a solid foundation in late stage clinical trials management.

Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements. Our operational model is based on a robust technology platform to support remote centralized management of our clients’ sites, and our operating procedures are designed for a post-approval setting.

Early Post-Approval Planning
We help our clients protect their investment with early post-approval planning.

Medical Information and Professional Contact Center
Our medical communications team provides high-quality, customizable programs that communicate essential product information to our customers quickly and cost-effectively.

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

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

Registries and Observational Studies
We deliver essential knowledge about drug use and treatment outcomes in real-world clinical practice through patient registries and observational studies.

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

Medical Device Development
Our experienced medical device specialists provide innovative, results-focused support for our customers’ clinical, regulatory and marketing needs.

Technology Services
Appropriate and effective technologies to meet the unique needs of post-approval studies.