Jamie Colgin, President of Colgin Consulting, Inc., helps pharmaceutical, biopharmaceutical, and contract research organizations assure the integrity of their preclinical and clinical data through risk assessments, integrated computer system compliance audits, mock inspections, remediation assistance, and 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.
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 relative to data integrity.
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.