CTC´s Pharmacovigilance department provides premarketing Pharmacovigilance service. The PV team includes our in-house Safety Officers and our in-house Medical Monitor.
EudraVigilance/SUSAR reporting service:
Our staff is certified Eudravigilance users, which is a requirement for expedited reporting of SUSAR. Reporting in EudraVigilance requires an approval from the authority for each sponsor and rapporteur. This process takes about 25 working days and should be in place before starting a clinical study. The medical monitor will judge each SAE based on the RSI (Reference safety information) if the SAE is expected or not. As EudraVigilance asks for unblinded cases, the individual code will be broken for each SUSAR and kept under strict confidentiality at our Pharmacovigilance department.
Medical Monitor service:
For our medical monitoring services we have a full time in-house experienced physician who is qualified for medical monitoring according to regulatory requirement. The medical monitor works on behalf of the sponsor, either alone or in close collaboration with the sponsor`s medical representative physician.
CTC PV´s medical monitor can assist in a broad range of services e.g. formal medical review of SAE/SUSAR including expectedness and causality assessment, oversight over safety management, assisting the investigator in safety issues, providing safety input to documents, informing Investigators of SUSARs etc. 24/7 service can be offered if requested.
Data Safety Monitoring Board (DSMB):
CTC PV offers all aspects of handling a DSMB. Everything from management, planning and documentation of DSMB meetings to set up a complete DSMB with suitable experts can be arranged for you.
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