The NC TraCS Regulatory service now provides quality assurance and study monitoring for investigator-initiated studies on a fee-for-hire basis.
The NC TraCS Regulatory service provides expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study. The service is now offering quality assurance and study monitoring 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. TraCS is providing a fee-for-hire monitoring service for investigator-initiated studies by assessing that their research has accurate, complete, and verifiable data. 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
Discover how TraCS Regulatory can help you with your clinical research!
For more information or to receive an estimate, please contact: Joyce M. Lanier
NOTE: Study monitoring services are offered at an hourly rate.