Safety Monitoring

Our Capabilities

Depending on your requirements, from bringing in novel cannabinoid-related compounds or conducting late-phase clinical studies, we will be able to provide a turn-key solution for your needs.

Safety Monitoring

Our medical team provides full local safety reporting services for all clinical trials. You will have a dedicated Clinical Safety Officer available 24/7 during your clinical trial. The Pharmacovigilance / Safety team is responsible for:

  • Safety Management
  • Creating Safety Reporting Plans and Safety Reporting Forms
  • Investigator and Site staff training on safety monitoring and reporting
  • SAE Narratives
  • Collection, evaluation, analysis and reporting of safety information

Expedited and Periodic Safety Report distribution to investigators 

  • Preparation and submission of Data Safety Update Reports (DSURs) and expedited reports (SAEs, SADEs, SUSARs, SUDARs) as per regulatory requirements and timelines.
  • Medical Coding of Adverse Events (MedDRA)