Abstract
While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. 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. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.
Highlights
Introduction to the Enhancing Quality in Preclinical Data (EQIPD) Quality SystemAnton Bespalov1*, René Bernard2*, Anja Gilis3*, Björn Gerlach1*, Javier Guillén[4], Vincent Castagné[5], Isabel A
At any step during the implementation, the use of EQIPD tools is voluntary and serves only the purpose of making the implementation and maintenance of the QS easier. Unless such information is available from other sources, the research unit may consult with the Toolbox to obtain relevant research quality-related information
The Dossier is a repository of documents and information that are specific to the user’s research unit and that is organized according to a structure suggested by EQIPD
Summary
Anton Bespalov1*, René Bernard2*, Anja Gilis3*, Björn Gerlach1*, Javier Guillén[4], Vincent Castagné[5], Isabel A. Institutes for BioMedical Research, Novartis Pharma, Basel, Switzerland; 10Pfizer, Silver Spring, MD, USA; 11Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands; 12The Myers Neuro-Behavioral. Magdeburg, Germany; 16Center for Behavioral Brain Sciences, Magdeburg, Germany; 17Medical Faculty, Otto-von-Guericke University, Magdeburg, Germany; 18Charles River Laboratories, Safety Assessment, Lyon, France; Current affiliation: ERBC Group, Baugy, France; 19Cohen Veterans Bioscience, Boston, MA, USA; 20German Mouse Clinic, Institute of Experimental Genetics, Helmholtz Zentrum. Germany; 22PAASP US, Ridgefield, CT, USA; 23The Stanley Center for Psychiatric Research, Broad Institute of MIT & Harvard, Cambridge, MA 02142; Cerbascience, Toulouse, France; 25PAASP France, Toulouse, France; 26Maj. Neurosciences, University of Lausanne, Lausanne, Switzerland; 32Institute of Medical. Brain Sciences, University of Edinburgh, Scotland, UK; 41QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Germany
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