For Directors of Quality Assurance who need to ensure the integrity of their clinical trial data, Colgin Consulting specializes in data integrity audits. Unlike Computer System Validation Consultants and Systems Auditors, our comprehensive approach
- clearly identifies your risks and issues
- links them to GCP regulatory requirements
- visually interprets them for easier understanding and communicating with your executive team or sponsors.
Your company’s research is changing lives.
We help keep you on that important journey and navigate the complications that can impact your clinical trials.
- What’s the risk? We can help you deliver a clear message to management.
- Staff over-stretched? Let us help lighten the load. We can audit independently or as part of your team.
- Negative inspection? We can help you craft a strong response.
- Acquiring another company? We can help you avoid surprises.
Meet Jamie Colgin, CISA, CRISC, ASQ CQA
Jamie Colgin is the President of Colgin Consulting, Inc., a consulting firm that helps Pharmaceutical, Biopharmaceutical, and Contract Research Organizations assure the integrity of their preclinical and clinical data through Integrated Computer System Compliance Audits, Mock Inspections, Remediation Assistance, and On-the-Job Training.
With over 20 years of hands-on experience in statistics, computer system validation, audits, and monitoring, Jamie has developed validated SAS programs to support GLP studies, managed the retrospective evaluation of hundreds of GLP and GCP systems, written policies and procedures, and set new standards for communicating audit findings by using process flow diagrams.
When you hire Colgin Consulting, you work directly with Jamie Colgin. We don’t outsource or subcontract.
Recipient of the prestigious Charles H. Butler Excellence in Teaching Award, Jamie can provide training for your audit staff focused on updating skill sets and understanding regulatory trends.
Prior to working in the pharmaceutical industry, Jamie proudly served with the US Peace Corps in the Philippines. She credits this experience for her resourceful nature.