The PREMIER project, funded for three years by the Volkswagenstiftung, aims to develop a structured quality assurance system for preclinical academic biomedicine. Since 2014 we are probably worldwide the only academic research institution that has maintained a certified quality management system in conformity with DIN EN ISO 9001:2008. Our familiarity with the advantages and disadvantages of a highly structured quality management stimulated our interest in developing a system better suited to academia.

We suggest to improve the quality of academic preclinical biomedicine with structured quality-ensuring measures. The existing approaches, norms and systems are resource-intensive and viewed as a threat to creativity, and are therefore widely scorned by scientists. We want to develop quality assurance tailored to academic biomedicine consisting of “building blocks” of quality-ensuring measures that are modular, scalable, practicable, financeable and acceptable for science.

Compliance with the quality standards therein established would be assessable through new forms of auditing (‘peer-auditing’). Conformity to the standards must be amenable to monitoring: we want to develop a new approach to monitoring that is not seen as invasive. It should support daily scientific practice in the laboratory. To convey the content of the measures and for training purposes we will develop e-learning resources. All concepts and resources developed are to be made available as “open source” material. Standards will be established in exchange of ideas with national and international scientists as well as with scientific organizations and sponsors, and complemented by meta-search.


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