Our aim is to provide credible scientific evidence to substantiate the safety and health benefits of our products for consumers, patients, healthcare professionals and authorities. To ensure our clinical evidence meets the highest quality standards, we design, conduct, analyze and report our clinical studies according to international laws and scientific and ethical guidelines, such as the International Conference on Harmonization of Good Clinical Practice (ICH-GCP) 1International Conference on Harmonization of Good Clinical Practice (ICH-GCP). https://pubmed.ncbi.nlm.nih.gov/10386329/ and the Declaration of Helsinki 2013 2WMA Declaration of Helsinki 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. We follow these laws and guidelines in selecting qualified investigators, obtaining independent ethics committee approvals prior to starting studies, conducting the studies and publishing the results of our clinical research.
Our Quality Management System for Clinical Research has been ISO 9001 certified since 2007, and has been recertified successfully every 3 years. This certification ensures our research methodology is aligned with ethical, scientific, and regulatory standards for clinical research. In line with our Quality Management System, we publicly disclose all clinical studies sponsored by Danone on publicly accessible trial registers (www.clinicaltrials.gov or www.trialregister.nl) prior to recruiting participants in clinical trials. Whenever we share clinical trial data, our priority is scientific integrity as well as safeguarding the privacy of individuals in accordance with all applicable data privacy regulations. Results of our clinical trials are shared by means of, amongst others, publications in peer reviewed journals, registering a summary of the clinical study results on public trial registers and/or publishing on a publicly accessible website. To ensure the results published are robust, we partner with independent external healthcare professionals and scientists in preparing, conducting and interpreting the results of clinical trials.
|1||International Conference on Harmonization of Good Clinical Practice (ICH-GCP). https://pubmed.ncbi.nlm.nih.gov/10386329/|
|2||WMA Declaration of Helsinki 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/|