Safety Monitoring

Safety Monitoring

 

Patient safety and risk mitigation are top priorities in every project.

Our monitoring services are provided by CRAs with the full support of senior management as required, and are available 24/7. Regular specific safety and therapeutic area trainings are an integral part of Atlant Clinical’s personnel development strategy.

Services include:

  • SAEs (Serious Adverse Events) reporting assessment
  • interface with Data Safety Monitoring Boards (DSMB)
  • safety information distribution among investigators
  • safety notification to regulatory authorities and/or ethics committees
  • medical monitoring of inclusion/exclusion criteria
  • medical monitoring plan preparation
  • therapeutic area training to CRAs and PMs