“Transforming Clinical Trials for Ultra-Rare Diseases”

At RealiseD, our unwavering mission is to accelerate the development of treatments for rare and ultra-rare conditions by changing the paradigm of clinical trials in ultra-rare diseases.

Our 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.

Our 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.

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Our Goals

Over 300 million people globally, including 30 million in Europe, live with a rare disease. The vast majority of the 7,000 identified rare diseases are ultra-rare (affecting 1 in 50,000) and have no approved treatments. RealiseD, is on a mission to change that.

We understand the challenges: small patient populations, varied symptoms, difficulties in enrolling participants to clinical trials, lack of standardised methodologies, fragmented regulatory frameworks and an inadequate infrastructure. But through innovative research methods and a collaborative approach, we’re breaking down these barriers.

“Our goal is to implement a collaborative and compRehensive mEthodological Approach to cLinical trIalS in (ultra-)rarE Diseases that optimises and speeds up the development of treatments for rare and ultra-rare conditions to improve the lives of millions”.

By bringing together experts from various fields, RealiseD will:

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. ERNs will also test RealiseD solutions in four areas – paediatric epilepsy, bone disorders, eye disease, and haematology.
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.

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“Transforming Clinical Trials for Ultra-Rare Diseases”

At RealiseD, our unwavering mission is to accelerate the development of treatments for rare and ultra-rare conditions by changing the paradigm of clinical trials in ultra-rare diseases.

Our 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.

Our Goals

“Our goal is to implement a collaborative and compRehensive mEthodological Approach to cLinical trIalS in (ultra-)rarE Diseases that optimises and speeds up the development of treatments for rare and ultra-rare conditions to improve the lives of millions”.

Latest news and updates

RealiseD project cited in Frontiers in Medicine: Advancing rare disease research

Successful Kick-Off Meeting for the RealiseD Project in Vienna

EMA Executive Director Emer Cooke Opens RealiseD kick off Meeting in Vienna with an Inspiring Keynote Speech

If you’d like to receive the latest updates of RealiseD directly to your inbox, please subscribe here.