A Proactive and Reactive Team in Orphan Drug Development

Published on: Nov 15th, 2022

Are you in need of a proactive and reactive team in orphan drug development? An orphan drug is a designation existing in both the FDA and the EMA regulatory frameworks. It has been created in order to facilitate access to medical support for those patients suffering from rare disease.

In this case study, we highlight the specific challenges of a biopharmaceutical company commercializing their drug candidate through the European framework for orphan drug indication. Our clinical research team worked proactively and reactively in orphan drug development, by providing tailored site management and study coordination for a phase II study operated in multiple sites… Find out more by downloading below!