PAREXEL International Corporation (NASDAQ:PRXL), a global biopharmaceutical services provider, announced that the Company has expanded its early phase drug development capabilities to provide biopharmaceutical companies with dedicated support for Proof of Concept studies.
Boston, MA, September 23, 2008 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has expanded its early phase drug development capabilities to provide biopharmaceutical companies with dedicated support for Proof of Concept studies. PAREXEL's new Proof of Concept unit integrates expertise and capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof of Concept studies are mainly conducted in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help clients avoid costly late stage clinical development failures by making better and faster go/no-go decisions
"As the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, companies are conducting a growing number of complex and rigorous Proof of Concept
studies. Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds,” said Herman Scholtz, M.D., Corporate Vice President, Early Drug Development, PAREXEL.
PAREXEL's dedicated team of experts provides clients with the required scientific, therapeutic, and regulatory expertise to design and implement Proof of Concept studies for new drug entities across a broad range of therapeutic indications. This team offers customized solutions including the appropriate use of biomarkers and adaptive trial designs. Adaptive designs are supported by specialized biostatistical expertise and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory as well as electronic data capture to provide rapid access to study data.
To accelerate patient recruitment, the Proof of Concept service offering provides PAREXEL SuperSitesSM capabilities in combination with a broad, global network of investigator and academic sites. PAREXEL SuperSites solutions leverage PAREXEL's hospital-based Clinical Pharmacology Research Units to provide high patient enrollment potential, drawing on dedicated recruitment specialists and relationships with local, hospital-based
physicians as well as using on-site call centers and database capabilities. This allows for a high number of patients to be recruited at these units in a shorter time frame, reducing the overall number of investigator sites, and ultimately decreasing time and cost.
For more information about PAREXEL's early phase development capabilities, visit: http://www.parexel.com/early_phase.html.