We offer quality assurance and study monitoring services for clinical trials that are not routinely monitored by any other entities.

Quality Assurance / Study Monitoring

We offer quality assurance and study monitoring services for clinical trials that are not routinely monitored by any other entities.

Clinical trials are monitored to ensure compliance with the approved protocol, federal regulations, and institutional policies. Quality assurance involves the early identification of problems or potential problems in study conduct.

We provide a fee-for-hire monitoring service for investigator-initiated studies by assessing that their research has accurate, complete, and verifiable data. Study monitoring services are offered at an hourly rate.

Services include:

  • Regulatory File Review
  • Source Documentation Verification
  • Informed Consent Review
  • Patient Eligibility Confirmation
  • Protocol Compliance Review
  • Investigational Product & Pharmacy Monitoring
  • Assessment of Safety Reporting Requirements
  • Review of Training Records
  • Development of Study Monitoring Plans

For more information or to receive an estimate, please contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

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Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599

919.966.6022
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CitE and SUBMit CTSA Grant number - UL1TR002489

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