Pharmacovigilance and Safety Monitoring
Optimus Clinical Research is committed to safeguarding patient safety through rigorous pharmacovigilance and safety monitoring. We manage and assess adverse events with precision, ensuring compliance with regulatory guidelines and timely reporting to authorities. Our proactive approach includes thorough risk analysis and robust safety measures to maintain the integrity of clinical trials.
Adverse Event (AE) and Serious Adverse Event (SAE) Management
- Monitor and assess adverse events and serious adverse events authorities, and ethics committees/institutional review board.
- Perform risk analysis and ensure that safety measures are in place throughout the trial.
Regulatory Reporting & Compliance
- Ensure compliance with pharmacovigilance regulations (DRAP, International regulations/sponsor guidelines etc.) for AE/SAE reporting.
- Manage the collection and documentation of safety data, ensuring timely and accurate reporting.
