Quality Management System
To ensure high-quality services in multinational clinical trials and more, we use a quality management system (QMS) which is ISO 9001:2015 certified. The QMS is fit-for-purpose and has been adapted to our distributed infrastructure. It certifies ECRIN's principal services.
The ECRIN QMS 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)). It aims to coordinate and structure the organisation’s activities to meet customer and regulatory requirements, and to improve effectiveness and efficiency on an ongoing basis.
ECRIN was awarded its ISO 9001:2015 certification on the 30th of November 2020, by the French Standards Association (AFNOR). This certification is renewed annually to ensure ECRIN continues to offer high-quality services to its users.
Scope and Application
ECRIN’s QMS covers all activities performed or delivered by the organisation and aims to ensure excellence in these activities. ECRIN’s current activities covered by its QMS and ISO 9001:2015 certification are:
- Coordination of operational services to the management of multinational clinical trials in Europe
- Capacity development through participation in infrastructure development projects
- Certification of data centres that provide data management services for non-commercial controlled clinical trials
ECRIN QMS applies to the following functional areas: ECRIN core team, ECRIN in-country teams (the European Correspondents) and any other functional entities, involved in ECRIN activities and services, whose roles and responsibilities are described in the ECRIN quality documents.
ECRIN must ensure that delivered services meet the Sponsor’s expectations and are compliant with regulatory and quality requirements.
Quality as a Service through Data Centre Certification
ECRIN offers Quality as a Service through its data centre certification programme. ECRIN’s certification programme assesses academic data management centres (primarily in ECRIN Member/Observer countries) for compliance with published ECRIN data standards, using an on-site audit of the unit’s data management activities and of the IT infrastructure used to support those activities.
Discover ECRIN Data Center Certification