Robust quality management is a cornerstone of biomedical research. It not only builds trust in the research and its results, but also helps research deal carefully with existing and invested resources. EU-AMRI supports cutting-edge research of the highest quality with a diverse service portfolio spanning the entire research workflow, including biobanking, clinical trials and translational medicine.
BBMRI-ERIC Quality Management Services for Basic and Applied Research span four pillars: Knowledge Hub, Training & Support, Auditing and Quality Assurance.
Consult our experts: BBMRI has delegates on technical committees with the ISO and CEN. BBMRI can draw from expertise across Europe, with over 150 quality experts in our 21 member and observer states. Each member has one quality lead within the National Node as point of contact for national questions on quality in biomedical research.
Receive training: Our trainings such as a 16-session training on pre-analytical standards relevant for biomedical research and biobanking, and a 22-session training on the international standard “General Requirements for Biobanking, ISO 20387:2018”, are free to those in our member states and will be woven into our upcoming BBMRI.QM Academy.
Get your Q-Mark: Interested biobanks can fill out a Self-Assessment Survey and schedule a remote or on-site audit with BBMRI-ERIC. A successful audit will lead to a Q-Mark in the BBMRI-ERIC Directory, a catalogue of samples and data from nearly 700 biobanks. Researchers can filter their search to find Q-Mark collections and biobanks and be assured that they have been gathered according to international standards.
EATRIS Quality Initiative (EQI) covers activities ranging from reproducibility, best practice guidelines, benchmarking and standards to reference materials. EATRIS involves its member facilities in international consortia that address data quality and reproducibility in translational medicine in order to boost the quality of scientific activities, for example by organising or participating in multi-site benchmarking studies.
ECRIN’s Data Centre Certification programme serves to audit European, non-commercial data centres using ECRIN IT/DM standards. By undergoing this audit such data centres prove that they can provide compliant, effective, and efficient data management services for controlled clinical trials. The overarching aim is to improve high-quality data management services in non-commercial clinical trials and to contribute to the harmonisation of European practice in data management.
ECRIN's quality management system (QMS) is ISO 9001:2015 certified for its principal services. The QMS is fit-for-purpose and has been adapted to its distributed infrastructure. It follows a risk and process-based approach, which is founded on the recommendations of the ISO 9001:2015 standard and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP E6 (R2). ECRIN was awarded its ISO 9001:2015 certification on the 30th of November 2020, by the French Standards Association (AFNOR), and applies to the following functional areas: ECRIN core team, ECRIN in-country teams and any other functional entities, involved in ECRIN activities and services, whose roles and responsibilities are described in the ECRIN quality documents.
Go to ECRIN’s Quality page