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Good People Working on Good Projects with Good Process

Case Study 2: Risk Based Monitoring


Situation The IRB determined a small company’s clinical trial did not meet regulatory requirements.
Frestedt Approach
  • Provided an appropriate risk-based monitoring plan
  • Received IRB approval
  • Trained the study staff accordingly
  • Completed the risk-based monitoring and advised changes to the company’s Quality Management System (plan, work instructions, forms)
Results The clinical trial issues were resolved in a timely manner with good clinical practices (GCP) in place for future clinical endeavors.