Study Monitoring Service

Study Monitoring Service

Per the FDA, all investigator initiated trials that are regulated by the FDA, require study monitoring. Study monitoring is required for all FDA regulated trials that are The CTO provides comprehensive study monitoring and auditing services that are based on the latest Risk Based Monitoring guidelines from the FDA. Thus, the service will cut down on the total monitoring volume and therefore the total time spent monitoring of clinical trials while achieving optimum levels of data review to ensure compliance and patient safety. The CTO will perform the following activities for your trial:

  1. Develop a monitoring plan that details staff training, all proposed visits and budget.
  2. The CTO will conduct monitoring visits, both on-site and remote, per the monitoring plan
  3. Assess and track SAEs and AEs and theu reporting to appropriate regulatory bodies
  4. Meet with study teams and PIs to keep them updated with study progress
  5. Provide support for FDA audits
  6. Conduct routine, on-demand QA/QI for ongoing trials