CARLSBAD, CA – March 5, 2013 – Agility Clinical, Inc., a specialty consulting and clinical research organization, has partnered with PSR Orphan Experts, a European orphan drug specialty consulting and clinical research company, based in the Netherlands, a move that will provide clients with access to orphan drug development expertise and services on both sides of the Atlantic. The term “orphan drug” refers to pharmaceutical products developed specifically to treat rare diseases. A rare disease is one that affects fewer than 200,000 Americans or less than one in 2,000 Europeans.
Carlsbad-based Agility Clinical and Netherlands-based PSR specialize in orphan drug development, helping pre-clinical and clinical stage companies, by providing strategic and operational consulting support, in addition to traditional CRO services. Both firms specialize in developing complex clinical development programs that require innovative regulatory and clinical development approaches.
“We’re excited to mutually benefit from the collaboration and expertise of the two firms, and see a growing need in this important area,” says Ellen Morgan, Agility CEO and 30-year industry veteran. “With few CROs focused on rare diseases, partnering with another like company to share knowledge and experiences strengthens our services to clients, and our reach.” Prior to joining Agility, Morgan co-founded and was CEO and chairman of a California-based CRO that grew to over 300 employees and provided clinical services to hundreds of companies during her tenure.
“Given the current challenges in orphan drug development, it is of crucial importance to provide innovative & solid infrastructure and expert services,“ says Roger Legtenberg, CEO of PSR Orphan Experts. “By further strengthening the geographical reach for both companies to both sides of the Atlantic, we are able to provide an efficient clinical drug development strategy to our clients.”
The number of rare diseases for which no treatment is currently available is estimated at approximately 6,800, according to the National Institute of Health (NIH). Nearly 30 million Americans, almost 1 in 10, are affected by a rare disease. Orphan drugs present fundamentally different regulatory and operational challenges than their traditional drug counterparts. Agility and PSR both specialize in helping companies develop efficiencies and economies of scale to help patients with rare diseases by bringing innovative new drugs and devices to market.
About Agility Clinical
Agility Clinical, founded in April 2012, with an experienced executive management team whose mission is to help small and virtual pre-clinical and clinical stage companies develop drugs and devices, particularly in the orphan drug category. In addition to consulting, Agility provides customized full clinical trial services including project management, clinical operations, data management, biostatistics, medical, regulatory, and scientific affairs, medical writing and electronic source records (ESR). The Agility team has a true appreciation for the challenges its clients face in obtaining the expertise they need. The firm’s senior staff volunteers time with its partner, the Public Health Alliance for Clinical Trials (PHACT), the first non-profit CRO dedicated to conducting clinical trials for products to treat diseases that affect the poorest people in developing countries.Agility has established operations in Carlsbad, CA. For more information, visit www.agility-clinical.com and http://www.phactcro.org.
About PSR Orphan Experts
PSR Group B.V., established in 1998, is a leading expert in orphan drug development in Europe. PSR assists companies to design and execute successful clinical development strategies for orphan indications, thereby specializing in complex clinical development programs requiring innovative regulatory and clinical approaches. PSR’s services range from regulatory & clinical consultancy to full clinical research services (project management, monitoring, regulatory affairs, electronic data capture/data management and statistics/medical writing). For more information, please visit http://www.orphandrugexperts.com.
Contact: Amy Zimmerman