ClinOpsHub

We are thrilled to announce the successful completion in 2025 of the THESEO project ( Tuscany Health Environment Site Empowerment Operation ), a strategic initiative led by ClinOpsHub S.r.l. to map, value, and strengthen the clinical research ecosystem in the Tuscany region. This project represents a significant milestone in positioning Tuscany as a leading European hub for high-quality clinical experimentation.  Project Framework and Funding   The THESEO project was funded through the...

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 . While the EU...

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).