Patient Registries & Observational Studies
PPD delivers essential knowledge about drug use and treatment outcomes in real-world clinical practice through our post-approval patient registries and observational studies group. Our epidemiology, operations, safety and therapeutic experts design and implement the ideal study to:
- Meet market challenges successfully
- Address FDA safety commitments
- Collect the data you need to demonstrate your product's true value
Our Scope of Service
We have successfully managed observational studies ranging in size from a few hundred sites and patients to those involving thousands of sites, tens of thousands of patients and all major therapeutic areas. A dedicated operations group will design and manage your non-interventional clinical research programs. These observational study programs include:
- Disease or patient registries
- Post-approval product registries
- Post-approval safety surveillance studies
- Pregnancy registries
- Research-based physician education programs
Patient Registry & Observational Study Services
PPD provides the following services:
- Clinical monitoring and quantifying risk potential by collecting real-world safety data
- Assessment of real-world patient outcomes, including quality of life and treatment satisfaction to better communicate product value
- Development and execution of observational studies to provide understanding of product effectiveness in broader patient populations than controlled clinical trials
- Identification of disease and treatment challenges to develop evidence-based treatment guidelines
Health Outcomes
Measuring health outcomes is often a key objective for registries and observational studies. PPD's experience includes the design and implementation of instruments to collect:
- Physician practice patterns and decision drivers
- Quality of life
- Health/functional status
- Health care resource utilization
- Treatment satisfaction and preference
- Patient adherence
- Time and motion assessments
