Parexel has expanded its early phase drug development capabilities with a dedicated unit to provide biopharmaceutical companies with support for proof-of-concept studies. The new unit integrates capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof-of-concept studies are mainly used in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help avoid costly late stage clinical development failures.
"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.
A dedicated team will provide clients with the required scientific, therapeutic, and regulatory services to design and implement these studies for new drug entities across a range of therapeutic indications. This team offers solutions including the use of biomarkers and adaptive trial designs, which are supported by biostatistical 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 EDC to provide rapid access to study data.
The proof-of-concept service offering provides the company's SuperSites capabilities together with a global network of investigator and academic sites to help accelerate patient recruitment. The SuperSites solutions use the company's hospital-based Clinical Pharmacology Research Units, drawing on recruitment specialists and relationships with local, hospital-based physicians as well as on-site call centers and database capabilities.
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