Patient safety oversight and documentation, SMP development, and SAE reconciliation
Patient safety is the number one priority of all studies conducted at Trial Runners. Our safety team and medical monitors, who are all experienced ophthalmologists, 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. Trial Runners will also regularly perform SAE reconciliation to ensure consistency between the safety and clinical databases.
Drug Safety Services
- Patient safety oversight during clinical trials
- Creation of safety management plan (SMP)
- Submission of SAEs to regulatory authorities
- Documentation tracking and filing via CTMS
- AE and SAE reconciliation of safety and clinical databases