New web-based technology platform for late phase clinical research

PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, today announced that it has introduced a new web-based technology platform for late phase clinical research to meet the expanding regulatory and commercialization needs of the biopharmaceutical industry. The platform brings greater cost effectiveness to conducting large-scale studies and facilitates highly efficient capture of global safety and health outcomes data in a real world setting. Demonstrations of the platform will be provided at the PAREXEL booth #313 during the Partnerships in Clinical Trials Conference to be held April 12-14, 2010 in Orlando, Florida.

The solution integrates the innovative strategies and proven processes of PAREXEL's PACE™ (Peri Approval Clinical Excellence) team with eClinical solutions from Perceptive Informatics, PAREXEL's technology subsidiary. This approach helps biopharmaceutical companies ensure higher data quality, accelerate better decision-making, and achieve faster determination of evidence-based health outcomes in late phase clinical research.

"Post-approval studies have continued to expand measurably in number, size, and complexity in recent years. As a result, biopharmaceutical companies require much greater efficiency in managing the high volume throughput of data while controlling the costs related to these programs. We are focused on helping clients achieve greater efficiency by gathering more data at a significantly lower cost per patient," said Carol Collins, Ph.D., Corporate Vice President and Worldwide Head of PACE, PAREXEL International.

According to Dr. Collins, "A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities in order to meet increasing regulatory and payer demands for long-term safety and health outcomes data.  This new technology platform reinforces our commitment to assist clients in generating more robust product safety and heath outcomes profiles."  

The platform includes many features and benefits to bring greater efficiency to late phase studies, such as:

• A streamlined user experience with single access
• An intuitive interface with functionality for site self registration and management
• Automated cues for unique late phase site requirements to enable improved compliance
• Enhanced reporting capabilities including site-based features such as investigator payment status reports
• Centralized access to data including site, patient, and clinical supply information

The platform allows for a broad range of eClinical solutions, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), and Electronic Patient-Reported Outcomes (ePRO), to be incorporated in late phase studies for optimal data integration.

PAREXEL's PACE™ (Peri Approval Clinical Excellence) team provides customized strategic and scientific solutions to facilitate the transition from product development to commercialization in a seamless and cost-effective manner. Over the past five years, the PACE team has conducted over 600 late phase studies, throughout 76 countries, which have involved more than one million patients and over 90,000 physician sites. PAREXEL's late phase capabilities include Phase IIIb and IV clinical trials, observational studies, registries, expanded access programs, risk management programs, post approval safety surveillance, and comparative effectiveness research as well as health economics and outcomes research consulting.