SAFETY MONITORING
Patient safety and risk mitigation are always top priorities.
Atlant Clinical administers regular safety and therapeutic-area trainings, as a fundamental strategy of personnel development. Our medical monitors are available 24/7.
Services include:
- medical monitoring plan preparation
- medical monitoring of inclusion/exclusion criteria
- therapeutic-area training to CRAs and PMs
- assistance in SAEs (Serious Adverse Events) reporting to investigators
- interaction with Data Safety Monitoring Boards (DSMB)
- proper distribution of safety information among investigators
- safety notification to regulatory authorities and/or ethics committees