2 December 2008, Raleigh, N.C. — PRA International, a leading Clinical Research Organization (CRO), announced today a collaborative agreement with Frontage Laboratories Inc. This partnership enables PRA Early Development Services’ US Clinical Pharmacology Center (PRA EDS US CPC) to now offer a full complement of analytical lab testing services to its existing Phase I – IV clinical trial services in North America.
PRA’s state-of-the-art, 80-bed Lenexa clinical facility near Kansas City, Missouri, runs a multitude of Phase I and Phase IIa studies each year, with a particular focus on first in human studies and other complex PK studies. By meaningfully broadening its bioanalytical service portfolio, PRA now offers Pharma and Biotech sponsors and other CROs the ability to align the clinical and laboratory processes, thus saving time by avoiding unnecessary clinical trial delays. It already operates a comparable full-service offering in Europe.
Although PRA conducts clinical trials across a broad spectrum of therapeutic areas, it has a special emphasis in the areas of oncology, central nervous system, allergy/respiratory, cardiovascular disorders and infectious diseases. Frontage Laboratories Inc. is fully compliant with cGMP/GLP regulations and under this new collaboration will offer specialized bioanalytical services via PRA. The new collaboration also offers pharmacokinetic & biostatistical consultancy and data support (including data management, biostatistical and PK/PD analysis and ICH-compliant report writing). Frontage operates a bioanalytical and biomarker research center of excellence in Malvern, PA (near Philadelphia), that houses 17 mass spectrometers and other state-of-the-art instrumentation. Frontage Laboratories’ client focus and project management efforts align well with PRA’s strategic initiatives.
Dr Wim Tamminga, Senior Director, PRA EDS US CPC commented, “We selected Frontage Laboratories as part of our strategy to offer clients a seamless package consisting of clinical and laboratory services,. This service allows us to accelerate Phase I studies and to give sponsors the ability to make better decisions earlier in the drug development process. Frontage is the right partner for this collaboration because they are already a well-established provider of cGMP/GLP compliant testing services. Quality of service, location, and scientific knowledge are what make Frontage Laboratories the best collaborative partner for our bioanalytical services.”
Song Li, CEO, Frontage Laboratories, Inc. also noted, “We are delighted that PRA chose Frontage Laboratories to assist in delivering service excellence to all clients and customers across the United States. Our scientific team is recognized industry wide for their expertise in solving complex bioanalytical method development issues quickly and cost effectively, allowing our clients to advance to Phase I studies faster. We look forward to building a collaborative relationship with PRA that not only streamlines project execution but also places a strong emphasis on project management.”
With more than 3,300 employees on six continents, PRA delivers reliable service, program-level therapeutic expertise and easy global access to knowledge. PRA offers a broad array of services that encompass the entire spectrum of clinical development, from filing of Investigational New Drug (IND) and similar regulatory applications to product registration and post-marketing studies on a global basis.
About PRA International
PRA International is a global Clinical Research Organization providing services through all phases of clinical development. Although we specialize in Oncology, CNS, respiratory/allergy diseases, cardiovascular and infectious diseases, we perform studies in all therapeutic areas. PRA has supported over 2,100 clinical trials through its 30 global offices. PRA’s therapeutic expertise, global reach and project experience, combined with local knowledge, enable our project teams to deliver consistent and on time performance for our clients. PRA’s Early Development Services (EDS) group provides comprehensive services for Phase I and Phase IIa studies, including: Phase I and IIa clinical research, bioanalytical research and data support.
To learn more about PRA International, please visit http://www.prainternational.com, email endpoints@praintl.com or call our Global Headquarters at +1 (919) 7868200.
For more information on PRA bioanalytical services, please contact Peter Ketelaar, Vice President Bioanalytical Laboratory at KetelaarPeter@PRAIntl.com or phone: +31-653-335-810
About Frontage Laboratories Inc.
Based in Malvern, PA, Frontage Laboratories, Inc. is a full service, collaborative research and development company that provides bioanalytical and biomarker services, pharmaceutical analysis, formulation development, GMP clinical trial materials (CTM) manufacturing and preclinical study services. Frontage is facilitating the rapid development of NCE’s and generic products through its operations in the US and China. Frontage assists its clients with resolving complex product development issues and advancing drug candidates through preclinical and clinical development stages to commercialization.
For more information about Frontage and its services, please contact Ron Connolly, Sr. Vice President Operations at rconnolly@frontagelab.com, visit the website www.frontagelab.com, or phone +01-610-232-0100
