PPD GlobalView Streamlines Study Logistics

Case Study

Post-approval studies demand a different operational approach for many reasons. Completing these studies in a timely and cost-effective manner is critical for product success. With all of the study options available, this type of research needs a technology platform capable of flexibility and customization.

PPD recently conducted a prospective longitudinal, multicenter observational study of subjects with Immune Thrombocytopenic Purpura (ITP), designed to assess clinical outcomes, physician practice patterns and patient-reported outcomes.

The rarity of the disease called for a global study involving approximately 300 sites across eight countries in three continents. To streamline logistics, the sponsor wanted an electronic data capture (EDC) solution for data collection and study management. However, an all-encompassing system would be impractical and cost-prohibitive due to the abbreviated data collection of critical variables related to standard of care.

After learning more about the study design and the need for data collection both retrospectively and prospectively, PPD recommended PPD GlobalView, a proprietary EDC application developed to conduct global registries and post-approval studies. As a result, PPD GlobalView provided these benefits:

• Ease of use: As an observational study, many research-naïve physicians were involved. With an easy-to-use, intuitive interface and simple navigational tools, PPD GlobalView facilitates quick adoption. In addition, the system only requires a standard Web browser and Internet connection; no special software is needed. Ease of use is essential for motivating site performance in a post-approval environment.
• Flexibility: When data collection requirements called for additional programming mid-study, these requirements were accomplished seamlessly without taking the system offline, avoiding a major disruption to the study.
• Cost-effectiveness: Post-approval studies often involve limited data capture, monitoring and data cleaning.  EDC systems developed for the rigor of Phase II-III studies can be cost-prohibitive for observational studies, but with PPD GlobalView, you can scale the system to meet the needs of a particular study.

PPD GlobalView utilizes open, front-end Web architecture to combine an Oracle relational database backend with the clinical utility of PPD’s proprietary user interface. Each deployment is developed as a project-specific EDC solution.   To date, this system has been used by more than 3,500 sites in 69 countries to enter and manage data for more than 50,000 patients.