The Annual Safety Report (or Development Safety Update Report) is an annual report that summarizes and evaluates the safety of a drug under development to provide an annual review of safety information and identify any new safety issues that could affect the drug's benefit-risk balance.   Among all the elements outlined in the ICH E2F guideline , there is one section that gives real purpose to the Development Safety Update Report (DSUR): the cumulative safety assessment . Whi

In October 2025, the European Medicines Agency (EMA) published updates on the implementation of the EU Clinical Trials Regulation (“CTR” No. 536/2014) and the development of the Clinical Trials Information System (CTIS).

In 2024, ClinOpsHub Srl obtained the   Gender Equality Certification UNI/PdR 125:2022 ,  a recognition that demonstrates the...

ClinOpsHub , a dynamic Italian CRO headquartered in Mesagne (BR), not only delivers high-quality pharmacovigilance (PV), quality,...