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ClinOpsHub
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Altre azioni
Profilo
Data di iscrizione: 8 apr 2021
Post (32)
17 feb 2026 ∙ 2 min
Empowering Clinical Research in Tuscany: The Successful Conclusion of the THESEO Project
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...
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26 nov 2025 ∙ 2 min
Writing the Annual Safety Report (DSUR) under the EU CTR: Cumulative Safety Assessment focus
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...
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10 nov 2025 ∙ 4 min
EMA Highlights – October 2025
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).
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