Services: Post-Approval

Our strength in late stage drug development derives from our strategic expertise and experience in Phase IV trials. Our custom-tailored processes, fine-tuned across the globe to meet local regulatory requirements, allow us to efficiently manage Phase IV trials worldwide.

PPD’s global technology infrastructure enables us to implement cost-effective, resource-efficient, centralized management of Phase IV trials as well as other late stage studies. Our post-approval group explores and implements a wide range of strategies to capitalize on the strengths of your product and maximize its life cycle.

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
High-quality, customizable programs and seamless integration communicate essential product information quickly and cost-effectively.

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