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