CARLSBAD, CA – December 2, 2014 – For its second consecutive year, 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 annual Rare and Orphan Advocacy and Research (ROAR) Awards.
ROAR awards honor achievements by organizations and individuals from the pharmaceutical and device industry, as well as patient and rare disease advocacy communities. This year’s ROAR awards were announced at The Annual World Orphan Drug Congress Europe, November 12-14, 2014, in Brussels Belgium.
“We’re thrilled that our commitment to innovating clinical development strategies for clients developing orphan drugs has been recognized consistently during our company’s first two years,” says Ellen Morgan, CEO of Agility. “Our vision for making a difference by dedicating ourselves to this specialty has become a reality.”
“Successively winning this award as the PSR-Agility Orphan Drug Development partnership is a clear appreciation by all stakeholders of our continued commitment in the rare disease community,” says Roger Legtenberg, CEO of PSR Orphan Experts.
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. Orphan drugs present fundamentally different regulatory and operational challenges compared to their traditional counterparts. 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.
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
Contact: Amy Zimmerman