Our Pharmacovigilance guarantees the proper management and sharing of all safety information through the clinical trials entrusted to us, in accordance with ICH GCP, current law and SOPs currently in force for each Project. We properly document and report each non-serious and serious adverse event to the applicable regulatory authorities. We also manage the reporting of ADRs to ECs and keep the general file and Data Base updated.
- Reviews the case report form (both p-CRF and e-CRF) against the subject’s medical record and source for completeness and accuracy
- Contacts investigators about SAE report and safety issues and checks completeness and consistency of information.
- Checks specific sections about safety in the study protocol, monitor manuals and other study materials produced.
- Keeps the study register updated of all AEs occurring during the trials.
- As mentor, trains new team members on safety data processing.
- SAE/AE reconciliation