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PSR-Agility Orphan Drug Development Wins ROAR Award For "Best Orphan Drug CRO"


11/21/2013 9:23:59 AM

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Hoofddorp, the Netherlands, November 21, 2013 / B3C newswire / – The PSR-Agility Orphan Drug Development partnership has been awarded “Best Orphan Drug Contract Research Organisation” in the Rare & Orphan Advocacy and Research (ROAR) Awards ( http://goo.gl/IYCTg8).

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 are an opportunity to recognize and honour achievements by organizations and individuals from industry, patient and rare disease advocacy communities.

“Winning this award as the PSR-Agility Orphan Drug Development partnership is an important acknowledgement 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. Our staff are all fully committed to the rare disease cause, taking part in fundraising events and other supportive activities.

“We established the PSR-Agility partnership so that our combined efforts in Europe and North America could make a difference for companies that are developing therapies for orphan products,” says Ellen Morgan, CEO of Agility. “Winning this award is a great confirmation that our efforts are working, and has made us even more motivated to continue our efforts.”

Orphan drugs present fundamentally different regulatory and operational challenges compared to their traditional counterparts. PSR-Agility Orphan Drug Development specializes in assisting companies to develop efficiencies and economies of scale to bring innovative new orphan products to market, thereby helping patients with rare diseases. Building successful partnerships with all stakeholders, including patient organizations, industry and key opinion leaders is of crucial importance. This is exemplified by the DevelopAKUre consortium, of which PSR Orphan Experts is one of the partners, winning a ROAR Award of the “Best European Industry-Patient Organisation Engagement”.

About PSR-Agility Orphan Drug Development

PSR Orphan Experts and Agility Clinical partnered early 2013 in order to benefit from a unique synergy and extend the partnership’s capabilities across the Atlantic.

PSR Orphan Experts was established in 1998 and has become a leading expert in orphan drug development in Europe. Agility Clinical, founded in April 2012 with an experienced executive management team, specializes in orphan drug development in North America.

PSR-Agility’s mission is to help small and virtual pre-clinical and clinical stage companies design and execute successful clinical development programs for orphan indications.

The partnership specializes in complex clinical development programs requiring innovative regulatory and clinical approaches. In addition to consulting, the partnership provides customized full clinical trial services including project management, clinical operations, data management, biostatistics, medical, regulatory, and scientific affairs, and medical writing. PSR-Agility has a true appreciation for the challenges its clients face in obtaining the expertise they need.

For more information, please visit http://www.orphandrugexperts.com and www.agility-clinical.com.

Media contact:

Roger J. Legtenberg

Chief Executive Officer

PSR Orphan Experts

+31 23 556 3221

roger.legtenberg@psr-group.com

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