Drug Safety
Our safety team and medical monitors, who are all experienced, will ensure proper patient safety oversight throughout the duration of your trial. A safety management plan (SMP) will be created that includes the requirements and procedures for the processing and reporting of serious adverse events (SAEs) during trials. All safety documentation will be tracked, filed, and readily available to our sponsors via our CTMS, which houses the safety database. TruMinds will also regularly perform SAE reconciliation to ensure consistency between the safety and clinical databases.
Drug Safety Services
- Clinical trial safety report receipt, review, assessment and follow-up
- Medical coding, narrative writing and follow-up
- Medical review, quality control and query resolution
- Analysis of Similar Events (AOSE) for US SUSAR reporting
- SUSAR report preparation and communication to
- Submission-ready individual case safety reports for health authorities
- Provision of line listings for database reconciliation with Data Management Plan
- Aggregate report preparation DSUR/IND Annual Reports
- Management of compliance and performance metrics
- Setup and configuration of a commercially available, fully validated safety database for each client
- Expertise and domain knowledge
- Project-specific issue management
- Product review activities (if required by HA or for proactive risk management)
- Quality Assurance including retrospective review of reports
- Case processing metrics review