Pharmacovigilance & Drug Safety
Pharmacovigilance is critically important for drug safety and development. Our Pharmacovigilance Team and Safety Officers report and manage adverse events. Clinmark also prepares periodic safety update reports, annual safety report, risk management plans, responses to regulatory authority queries and other relevant safety-related documents.
Safety monitoring is a mandatory activity during both clinical trials and post-market part of product lifecycle. We do not simply collect and report the event data our Safety Team is engaged in the process from the very beginning of the study set-up by reviewing study safety procedures and preparing AE, SAE, and device incident pages in eCRF. We closely cooperate with Data Management, Medical Monitoring, and Clinical Operations to streamline and simplify the reporting process with the help of state-of-the-art integrated databases. Clinmark Safety provides end-to-end service, meaning that all events (or incidents) are taken care of from data collection until regulatory reporting. While our daily work is based on internal procedures compliant with ICH requirements, we offer solutions tailored to Client’s needs as well as continuous support and consulting in all safety-related matters.
Our scope of work includes:
- Clinical trial safety
- Non-interventional studies
- Post-market spontaneous reporting
- Post-market surveillance (studies, literature, database review)
- Safety for medical devices (clinical studies and post-market)
- Aggregate reporting (PSUR, DSUR)
Standard safety services in clinical trials include:
- Review of safety procedures (CSP/CIP)
- Preparation of project-specific Safety Management Plan (SMP)
- Design of safety part of EDC (eCRF pages for: AE, SAE, Incident, etc.)
- Training for study teams (CTAs, CRAs, site staff)
- Safety data collection (continuous process)
- Safety data assessment and processing, narrative writing
- Reporting to Authorities and Ethics Commitees
- Cross-reporting of SUSARs between the sites
- Adverse event follow-up
- DSUR preparation
- Preparation of safety part of Clinical Trial Report
Being the Clinmark’s newest department, the Safety Team is constantly growing with new versatilely-experienced talents to deliver new top quality services.