CARLSBAD, CA – December 3, 2013 – Agility-PSR – the partnership between Agility Clinical, Inc., a Carlsbad-based specialty consulting and clinical research organization (CRO), and PSR Orphan Experts, a European orphan drug specialty consulting and clinical research company – has been awarded “Best Contract Research Organization” in the 2013 Rare and Orphan Advocacy and Research (ROAR) Awards.
The ROAR Awards were announced during the 4th Annual World Orphan Drug Congress Europe, November 14-15, 2013, in Geneva, Switzerland. The inaugural 2013 awards honor achievements by organizations and individuals from the pharmaceutical and device industry, as well as patient and rare disease advocacy communities.
“We established this partnership to strengthen our services and geographic reach for companies developing therapies for orphan products,” says Ellen Morgan, CEO of Agility. “Winning this award is evidence of the confidence our clients place in us and reflects our commitment to the highest standards of clinical research.”
“Winning this award is an important acknowledgment for our pioneering work in the rare disease community over the last 5 years,” says Roger Legtenberg, CEO of PSR Orphan Experts. “As a unique specialized service provider, our way of integrating innovative regulatory & clinical approaches and reaching crucial milestones for our clients has been the basis for winning this award.”
The term “orphan drug” refers to pharmaceutical products developed specifically to treat rare diseases, those affecting fewer than 200,000 Americans or less than one in 2,000 Europeans. Orphan drugs present fundamentally different regulatory and operational challenges compared to their traditional counterparts. Agility and PSR specialize in assisting companies in developing efficiencies and economies of scale to bring innovative orphan products to market, and to help patients and families affected by rare diseases.
About Agility Clinical
Agility Clinical was 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 and medical writing. 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
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