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Why manage Quality?

In the last few years, meta-research has identified substantial deficits in the planning, execution, analysis, and dissemination of results from biomedical research. Research findings are often not reproducible, even when published in prestigious journals. A “replication crisis” has been diagnosed, which may at least partially be responsible for the exceedingly high attrition rate when attempting to transfer promising results from preclinical research into clinically effective therapies. There is now a wide consensus that the biomedical sciences, especially their preclinical domain, are afflicted by a systemic quality problem. In response, as one of many potential remedies, we here propose to improve the quality of academic preclinical biomedicine through structured quality-ensuring measures.

Existing approaches, norms and systems are resource-intensive and hardly suitable for preclinical biomedical research, especially in academia where additional regulatory elements are viewed as a threat to creativity, and therefore widely scorned by scientists. To our knowledge, all existing research laboratory Quality Management Systems (QMS) have been developed outside of academia in environments where adherence to different types of regulation is required.

The widespread skepticism of scientists towards systematic quality management is based more on prejudice than on personal experience. Until now, there has been no QMS tailored to the specifics of the research process, work organization and personnel structure of academic biomedical research. PREMIER now offers scientists and research administrators the opportunity to pursue a more systematic and comprehensive approach to improving research quality in a modular way and with a low implementation threshold.