Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges. PRA understands these challenges and the critical success factors necessary to develop drugs for rare disease patients. It’s not a cookie-cutter formula, but rather a nimble approach that embraces the flexibility, creativity, and innovation needed to succeed in this arena. In the last 5 years, we have managed over 170 Phase I-IV rare disease studies, across 11 different therapeutic areas, resulting in the successful marketing approval of 16 drugs.
Data Monitoring Committee Unit
Due to increasing regulatory requirements, the need for quality study and patient safety data is critical as we work together to bring our clients’…
March is Bleeding Disorders Awareness Month
RARE DISEASES NEWSLETTER Volume 9, April 2018
This quarterly publication will keep you up to date on PRA’s Rare Disease Team focus, achievements, and new initiatives.