RealiseD

compRehensive mEthodological and operational Approach to cLinical trialS in ultra-rarE Diseases

Duration: 2025-2029

Budget: €17M (Horizon Europe Innovative Health Initiative)

Partners: 38 organisations

Coordinator: Sigmund Freud Private University and AstraZeneca

Vision

RealiseD’s ambition is to improve the lives of millions of people living with a rare and ultra-rare disease across Europe and beyond by developing cutting-edge operational and methodological tools and resources that can dramatically advance the evaluation of new treatments.

Mission

- Generate cutting-edge operational and methodological tools and resources through a co-creation process involving clinicians, methodologists, pharmaceutical industry researchers, representatives from patient organisations, regulatory agencies and HTA bodies.

- Collaborate with European Reference Networks (ERNs) to create a network of clinical trial sites across Europe and streamline the process of finding and enrolling patients in clinical trials.

- Accelerate therapeutic development and improve patient outcomes for over 30 million people living with rare diseases in Europe, most of whom suffer from ultra-rare diseases and have no treatment options.

- Establish new gold standards for clinical trials in rare and ultra-rare diseases through a partnership of nearly 40 public and private organisations.