PSR: the Orphan Drug Expert

PSR is the leading expert in orphan drug development. We assist our clients to design and execute successful clinical development strategies for orphan indications. We are specialized in complex development clinical programs requiring innovative regulatory and clinical approaches.

PSR understands the challenges of developing orphan and paediatric medicines and can draw upon extensive expertise to ensure the most appropriate design of the clinical program. Having established links with physician networks, key opinion leaders, scientific advisors, government bodies and rare disease patient groups, we can ensure the best design of your clinical program.

At PSR, we have the experience to set up and run orphan studies successfully. Our project managers are familiar with managing complex, multinational studies and know how to use novel approaches to gain access to patients and maintain protocol compliance. When managing our projects we create true partnerships with our clients, investigators, key opinion leaders and all other stakeholders in the program.