EU-PEARL

EU-PEARL had the ambition of transforming the then-current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients' interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing had the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL aimed to improve clinical effectiveness, patients' satisfaction, and societal access to timely and affordable medicines, and it was shaping the clinical trials of the future.

The main objectives of EU-PEARL were:

1. To create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross-company IRP in any disease area with unmet needs

2. To set up the open, dynamic, patient-inclusive IRP governance structure that will manage the appropriate regulatory, ethical, legal, statistical and data utilisation requirements

3. To disseminate and exploit the EU-PEARL paradigm through the provision of the necessary common tools, procedures, expertise and operational skills working to the highest scientific, regulatory and ethical standards and best practices

4. To create trial-ready IRP networks in the four disease areas of Major Depressive Disorder (MDD), Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis (NF)

i~HD led the main governance work package of the project and played a leading role in ensuring the project met its objectives. It had specific responsibilities in information governance and GDPR compliance, interoperability, and data quality, platform certification, and contributed to other sustainability actions.