QualityCR is an independent consultancy company based in the Netherlands and serves governamental institutions, research-oriented institutions (such as academia) and clinical trial sites with improving Good Clinical Practises. We offer independent Quality Assurance, Data integrity and Risk Management consultancy.
Apart from The Netherlands, we also focus on the Southern- and Eastern Europe and on the regions that need urgent support with quality, risk management and inspection readiness in clinical research.
Our services cover both inspection readiness and in-house or online trainings in a tailored approach in order to match your business needs.
The aim of our audits is to increase the quality of your clinical trials and to prepare you for second and third party inspections. By providing different types of GCP trainings, we intend to increase the awareness with respect to the quality of research with human beings (volunteers, patients, patient data and patient material). By doing so, your team will benefit of improved results, decreased time invested in obtaining these results and, at the same time, decreased costs by eliminating waste from different processes.
Daniela van 't Ent is the owner of QualityCR. She has obtained a Bachelor degree in Biochemistry, a Master in Biotechnology and a PhD in Medical Sciences from Radboud University Medical Center in Nijmegen, The Netherlands.
As a scientist, Daniela has gained working experience in different research institutes and companies, such as Janssen Vaccines and Prevention Center in Leiden, Roche Diagnostics GmbH in München, Institute of Polymer Research GKSS Research Center in Berlin, and the National Institute of Research Agronomique in Paris.
As clinical quality assurance officer, Daniela has obtained clinical experience during her work at the Research Unit at Vrij Universiteit Medisch Centrum in Amsterdam, where she developed audit plans and conducted more than 20 audits most of them concerning investigator-initiated clinical trials. Daniela has joined the GMP world and gained in depth QA experience in the manufacturing of sterile and non-sterile vaccines and medical radionuclear isotopes by working at HAL Allergy and at Mallinckrodt Pharmaceuticals.
Given the increasing importance of quality and risk management in clinical research, Daniela saw the possibility of applying her knowledge as scientist, together with her teaching skills and high quality standards in founding an independent consulting agency that guides scientific personnel, physicians and nurses with conducting high quality and compliant clinical sudies. Daniela is also a qualified lead auditor with experince in importation of IMPs.
Jennifer Benit is an independent advisor of QualityCR. Jennifer has obtained a Bachelor degree in Medical Biology at the Hogeschool van Amsterdam and a Master degree in BioMedical Sciences at the University of Amsterdam. In 2018 she obtained her Qualification in Education for Development and Implementation of Education at Universities in Netherlands.
With more than 20 years experience in academia in the Netherlands, Jennifer is now expert in the field of national and international laws, rules and guidelines related to clinical research. During the last 15 years Jennifer has been appointed as Head of the Clinical Research Center at Vrij Universiteit Medisch Centrum in Amsterdam where she lead various scientific projects.
Up to now Jennifer has developed and implemented several training courses (online and on paper) on various subjects pertaining to the design and conduct of clinical research and clinical trials. Additionally, she has been a pro-bonus project leader for a project in which different experts in the field were appointed to set-up a new clinic in Gambia http://www.funfoundation.nl.
Besides developmental and didactical experience in training of clinical personnel, Jennifer also has experience in advising the higher management of clinical centers, hospitals and universities on integrity risk management implementation. She actively develops training and compliance rules in relation with clinical studies.