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

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

With the launch of our Pharmacovigilance Department, we now offer specialized Pharmacovigilance (PV) services to support Sponsors, CROs...