FARGO, N.D., Oct. 2, 2012 /PRNewswire/ -- PRACS Institute and Alcmaeon Pharma today announced the signing of a partnership agreement for clinical development services. This exclusive North American development partnership complements each organization's core capabilities and extends their geographic reach to provide full-service development support to generic and biopharmaceutical companies spanning Phases I-III of clinical development.
"Working with Alcmaeon is part of PRACS' strategy to help foreign-based companies conduct early phase work and establish their product pipelines cost-effectively with quality data in North America," said James Carlson, Chief Executive Officer of PRACS Institute. "Canada provides an ideal drug development location for European sponsors through harmonized regulatory procedures and access to a diverse range of healthy participant pools and patient populations. In the U.S., our clinical pharmacology facilities have set new standards for expedited recruitment techniques and efficient study conduct."
"This partnership is one of several types that help biopharmaceutical sponsors access the right specialty provider throughout the drug development lifecycle and bioequivalence generic support," said George Tsolakos, Managing Director and Chairman of Alcmaeon Pharma. "Our approach allows for direct access to the functional provider, with central management by Alcmaeon. This way, the client avoids additional layers of study management, which reduces cost."
Under the terms of the partnership agreement, Alcmaeon will provide upfront planning and design services to clients. PRACS Institute will provide study conduct, as well as supporting backend data analysis and bioanalytical services.
PRACS Institute is an early phase clinical research organization providing comprehensive services and expertise to support product development of large and small molecules, novel compounds and generics. Three clinical pharmacology facilities have been designed to meet both standard and specialized study designs. Two bioanalytical facilities specialize in small molecule analysis. A full range of scientific affairs services, including PK/PD, biostatistics, data management and medical writing provide the supporting infrastructure to take projects from start to finish.
Alcmaeon Pharma is a pharmaceutical research management organization that assists clients in the design and management of clinical trials through an approach that combines more than 25 years of internal expertise, an established network of biopharmaceutical sponsors and a selection of vetted partners to provide full-service drug development services on a global scale.