close

Agreements

Date: 2013-03-05

Type of information: Collaboration agreement

Compound: consulting, orphan drug development services

Company: PSR Orphan Experts (The Netherlands) Agility Clinical (USA)

Therapeutic area: Rare diseases

Type agreement:

collaboration

Action mechanism:

Disease:

Details:

Agility Clinical, a specialty consulting and clinical research organization, has partnered with PSR Orphan Experts, a European orphan drug specialty consulting and clinical research company. This move will provide clients with access to orphan drug development expertise and services on both sides of the Atlantic. Agility Clinical and 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.

Agility Clinical, founded in April 2012, helps small and virtual pre-clinical and clinical stage companies to 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).
PSR Group B.V., established in 1998, is an 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).

Financial terms:

Latest news:

Is general: Yes