Registries and Observational Studies

PPD delivers essential knowledge about drug use and treatment outcomes in real-world clinical practice through our 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 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 programs include:

Disease registries
Post-approval product registries
Post-approval safety surveillance studies
Pregnancy registries
Research-based physician education programs

Services

PPD provides the following services:

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 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

We utilize these PPD services to support registries and observational studies:

Technology services, including PPD GlobalView and a fully validated integrated voice response system (IVRS)
Data management
Monitoring services
Global regulatory expertise

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