5 June 2023

DisCoVery publishes an article on management of pharmacovigilance during the COVID-19 pandemic crisis

Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial

During a pandemic crisis, sponsors should educate and train investigators about the importance of the pharmacovigilance issues.
•The assessment of the safety profile of the investigational medicinal drug is crucial in a clinical trial related to a health crisis, but needs to be adapted.
•In a pandemic crisis: the right balance must be found between collecting a lot of data and taking into account the investigators’ lack of time to provide these data.
•The added value of this work is that the management of safety during a clinical trial in the event of a pandemic needs to be simplified, pragmatic and prioritized to avoid increasing the workload of study staff and site investigators

link to the article: https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.1072