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 f...