Carlsbad, Calif.-based Agility Clinical, a specialty CRO, has partnered with PSR Orphan Experts, a 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 that affect fewer than 200,000 Americans or less than one in 2,000 Europeans.

Both companies specialize in orphan drug development for pre-clinical and clinical stage companies, 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.

“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,” said Ellen Morgan, Agility CEO and 30-year industry veteran.

“Given the current challenges in orphan drug development, it is of crucial importance to provide innovative and solid infrastructure and expert services,” said Roger Legtenberg, CEO of PSR Orphan Experts, which was established in 1998.

The number of rare diseases for which no treatment currently is 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 Clinical was founded in April 2012. The firm’s senior staff also volunteers with its partner, the Public Health Alliance for Clinical Trials (PHACT), the first nonprofit CRO dedicated to conducting clinical trials for products to treat diseases that affect the poorest people in developing countries.