Data Capture Capabilities

PRA focuses on helping the client choose the system that best meets the study's needs. That's why we have established both in-house systems and strategic partnerships that enable us to offer our clients a suite of paper, EDC, and hybrid solutions to optimize the CDMS for their trial. In addition to working in our own IT environment or an ASP scenario with a technology vendor, PRA has significant experience connecting remotely to client systems through a secure, direct-access connection.

Electronic Data Capture

The PRA Data Management group has considerable expertise in electronic data capture (EDC), having performed over 185 EDC studies across six continents. We actively use DataLabs^®, Medidata Rave^®, Phase Forward Inform^®, Phase Forward OutcomeLogix^® (patient-level EDC), and Oracle Clinical^® RDC. Our employees are fully trained and certified in the use of these systems, providing flexibility to clients who already have an enterprise solution selected.

PRA is committed to using our experience in this comprehensive suite of industry-leading EDC platforms to meet our clients' needs. This experience enables us to provide full services and training across any of these systems, regardless of client need. PRA performs all Data Management services and hosts data for studies in DataLabs and Oracle Clinical. This infrastructure often affords a lower-cost EDC solution to our clients. Additionally, we provide study-build and execution services for studies hosted in Medidata Rave and Phase Forward InForm, as we are partners with these technology vendors through their Medidata Rave ASPire to Win and Phase Forward Enterprise Adoption programs. These relationships enable the client to use industry-leading tools with the high-level support of PRA technical staff.

PRA understands the importance of providing quality training and timely support to clinical sites. Every Data Management office has EDC helpdesk staffed 24 hours a day, 7 days a week with EDC system-experienced PRA call center agents. Toll-free numbers are provided for all countries, and helpdesk calls are quickly routed providing the highest level of client support.

PRA has dedicated EDC experts who develop site and monitor training to ensure the most efficient use of the EDC applications. PRA provides computer-based, self-paced system training combined with protocol-specific training delivered by the Lead Data Manager and the Clinical Research Associates during a study. The client also can select additional live training options as needed to suit the studies and sites.

Traditional Paper-Based Studies

Since 1997, PRA has used Oracle Clinical, which is an industry-standard Data Management system particularly suited to manage complex, high-volume paper studies. We have implemented Oracle Clinical as a centralized system that each Data Management location can access. After we scan paper CRF pages at our central Document Management Center, we make electronic images of the CRF available globally for entry. The system includes:

Advanced functionality and flexibility to deal with complex study designs.
Global library capability to maximize the efficient re-use of study components.
Integrated tools for coding and the management of laboratory reference ranges.