About us

PSR is a leading expert in Orphan drug development. We provide the essential ingredients necessary to help our clients through the logistical and regulatory hurdles of clinical study programs for these products.

PSR has established links with physician networks, key opinion leaders, government bodies and patient groups; we can provide regulatory expertise and access to scientific (protocol) advice at the EMA level, all of which helps to ensure the best design of the clinical program.

PSR has the experience necessary to set up and run complex clinical trials in rare diseases, where access to patients and overcoming the logistical challenges of sparsely distributed patients are the keys to success. Our approach is tailored to enable us to perform efficient and successful orphan drug studies, which often require a small number of sites per country spread over several countries together with novel approaches to ensure protocol compliance.

Fore more information, please visit our main website: www.psr-group.com.