The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org) is a sustainable, not-for-profit, distributed infrastructure with the legal status of a European Research Infrastructure Consortium (ERIC); (PIC number: 948646712). ECRIN currently has nine Member Countries (Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal and Spain) and two Observer Countries (Switzerland and Slovakia).
.ECRIN has been offering trial management services for multinational clinical studies since 2009. As of 2019, its clinical trial portfolio includes 50 EU-funded, multinational clinical trials run in more than 20 countries (with a mean of seven countries per study), including both ECRIN Member and Observer Countries, as well as other countries in Europe and rest of the world. These trials cover various disease and medical areas and populations, different types of trials (medicinal products, medical devices, other intervention trials such as surgery, nutrition), and different clinical trial phases. Specifically, ECRIN is providing support for the IMI NECESSITY (GA 806975), a multi-arm multi-stage clinical trial to validate newly defined endpoints and biomarkers in Primary Sjögren’s Syndrome (pSS). ECRIN is also supporting projects on patient stratification and cohort integration, such as H2020 SYNCHROS and EU-TRAIN.
Furthermore, ECRIN has developed a core set of data standards for data management activities within an IT infrastructure. Based on these previously developed standards, ECRIN is coordinating a Data Centre Certification programme (ref 4), aiming to identify non-commercial clinical trials units in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data. So far, 11 Units have been certified according to this programme.
In addition, ECRIN is involved in projects targeting sharing and re-use of multimodal patient-level healthcare data (EHR4CR, CORBEL, EOSC-LIFE), with a strong focus on data sharing, data reuse (ref 5).