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Post-Approval

Post-approval services

Global Post-Approval Services

Providing extensive experience in post-approval studies and late stage research for customized risk management solutions.

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 the post-approval setting.

Early Planning

We help our clients protect their investment with early post-approval planning.

Medical Communications

Our teams provide high-quality, customizable programs that communicate essential product information to our customers quickly and cost-effectively.

Medical Writing

PPD offers a comprehensive suite of post-approval medical writing services.

Late Stage Research

Our project managers provide quality deliverables on time and on budget, resulting in effective post-approval programs, including Phase IV trials.

Research Coordination Center

PPD’s Research Coordination Center is a global center of expertise that focuses on remote site activities in support of late stage studies.

Registries & Observational Studies

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

Real-world Outcomes

PPD's real-world outcomes research delivers an important component of product development and commercialization services.

Pharmacovigilance

Delivers medical and safety services according to comprehensive, customized safety plans.

Risk Management & REMS

PPD has a full range of capabilities and extensive experience supporting risk management and REMS programs for clients.

Pregnancy and Lactation Studies

Review a list of PPD’s current pregnancy and lactation studies.

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