The German Mouse Clinic (GMC) has implemented the EQIPD (Enhancing Quality In Preclinical Data) Quality System in addition to a well-established ISO 9001 Quality Management System (QMS) (certified since 2014). Assessment by members of an EQIPD working group revealed compliance of the QMS at the GMC with the EQIPD standards and requirements leading to the certification in June 2021.
Poor-quality data is a challenge in drug development, negatively impeding the transition from preclinical to clinical use. Robust data and scientific rigor determine the pace of knowledge gain and the time needed to make new drug treatments available to patients. To support robustness and reliability of preclinical biomedical research in a collaborative manner, the Enhancing Quality in Preclinical Data (EQIPD) consortium was formed in 2017 with founding members from 29 institutions across eight different countries. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel and publicly available preclinical research Quality System for research labs to bring best practices to the lab by providing a systematic approach including tools, guidance and training. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. On top of these 18 requirements come research unit specific needs.
EQIPD’s aim is to enable a smoother, faster and safer transition from preclinical to clinical testing and drug approval by introducing a Quality System to strengthen the robustness, rigor and validity of research data.
The GMC, one of EQIPD’s stakeholders, was the first research institution assessed by EQIPD and was commended, inter alia, for the systematic approaches for documentation of standardized research studies, the extensive training program and the exemplary error culture.
Bespalov A, Bernard R, Gilis A, Gerlach B, Guillén J, Castagné V, Lefevre IA, Ducrey F, Monk L, Bongiovanni S, Altevogt B, Arroyo-Araujo M, Bikovski L, de Bruin N, Castaños-Vélez E, Dityatev A, Emmerich CH, Fares R, Ferland-Beckham C, Froger-Colléaux C, Gailus-Durner V, Hölter SM, Hofmann MC, Kabitzke P, Kas MJ, Kurreck C, Moser P, Pietraszek M, Popik P, Potschka H, Prado Montes de Oca E, Restivo L, Riedel G, Ritskes-Hoitinga M, Samardzic J, Schunn M, Stöger C, Voikar V, Vollert J, Wever KE, Wuyts K, MacLeod MR, Dirnagl U, Steckler T. Introduction to the EQIPD quality system. Elife. 2021 May 24;10:e63294. doi: 10.7554/eLife.63294. PMID: 34028353; PMCID: PMC8184207.