Program coordinating centers

Core to PAREXEL's peri-approval program success is the utilization of its global Program Coordinating Center (PCC) network with six locations in the Americas and Europe:

• Centerville, Virginia
• Buenos Aires, Argentina
• Paris and Orléans, France
• London, United Kingdom
• Berlin, Germany

The PCC specializes in cost-effective implementation of peri-approval studies by remotely conducting many of the activities typically handled by on-site monitors in pre-approval clinical trials.

Through an advanced telecommunications infrastructure, integrated workflow management technologies, and sophisticated, flexible data processing capabilities, the PCC excels at physician recruitment, regulatory document collection, contract execution and remote site management, including real-time data review and approval. Depending on the demands of the study, the PCC can either manage the study in its entirety or work seamlessly with on-site monitoring teams to complement their activities. All this translates into cost savings to PAREXEL's clients.

PAREXEL's PCC is staffed with clinical professionals who have prior healthcare experience and many have advanced degrees in clinical research and related disciplines. Through its implementation and management of peri-approval studies and registries, the PCC interacts with thousands of prescribing physicians on a routine basis. PCC staff members are also highly experienced in interacting with research-naïve investigators and their staff on a remote basis, which minimizes the burden of trial participation on their busy practices while maintaining protocol compliance and data integrity.

A high-level summary of the PCC's service offerings includes:

• Identifying potential sites from a large database of physician practices across various therapeutic areas.
• Conducting site screening and phone qualification.
• Performing regulatory document collection and contract execution activities.
• Training sites via remote Initiation call or webcast meetings.
• Remotely monitoring sites on a routine or ad hoc basis.
• Conducting remote termination activities to close out site.
• Providing general project management services, including leadership and metrics-driven reporting.

PAREXEL has implemented similar strategies for other peri-approval trials. These strategies have resulted in the successful achievement of project goals in a highly cost-efficient manner - without sacrificing data quality or the validity of these studies.

The PCC's client list includes large and small pharma, as well as biotechnology companies. Some of its studies have thousands of sites and patients while others have much fewer accruals. Data from projects utilizing the PCC have been used for FDA commitment studies, compassionate use programs, and peer-reviewed publications (including Tier 1 journals).

For more information on our global Program Coordinating Center networks, contact the PACE Group.