Our services involve marketed medicinal products, products under derogatory (early or compassionate) access, or products in clinical development
– Local (French territory) and regional (Europe) PV legislation monitoring
– Medical literature monitoring for product-related safety information
– Writing and submitting Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR)
-Writing and maintaining the EU-PSMF and the French local-PSMF
– Signal detection, assessment, and validation
– Individual Safety Case Reports (ICSR), Suspected unexpected serious adverse reactions (SUSAR) processing and reporting to competent authorities including MedDRA coding.
-Handling competent authority safety requests
If you want to learn more about the reporting of safety data in clinical trials, here is an overview: https://www.ema.europa.eu/en/documents/presentation/safety-monitoring-reporting-dr-ingrid-wallenbeck_en.pdf
Did you know that one of the main goals of safety management in clinical trials is to detect suspected unexpected serious adverse reactions (SUSARs)? check this study to learn more: https://pubmed.ncbi.nlm.nih.gov/29444478/
Do you want to learn more about the signal detection process? Check this page from the Uppsala Monitoring Centre: https://who-umc.org/signal-work/signal-detection/
ML PV and Medical Writing Consulting 