OBrien CQA, LLC is a consulting firm that provides the full spectrum of Good Clinical Practice services in the US and internationally.    We work collaboratively with sponsor companies to ensure that compliance with applicable regulations and guidance documents (ICH GCP, FDA Title 21 Code of Federal Regulations, Clinical Trial Directive 2001/20/EC, and GCP Directive 2005/28/EC) is achieved through the execution of Clinical Quality Assurance oversight, SOP development practices, and the auditing of internal processes/systems, vendor companies, and clinical investigator sites.

Jenny O’Brien is has been working in Clinical Quality Assurance and Regulatory Affairs for over fifteen years.  Her GCP QA expertise includes site audits, vendor audits, process mapping, mock regulatory inspections, pre-inspection site visits, SOP development, clinical quality program development, and other specialized clinical QA consultancy. In addition to her CQA experience, she has served as a Regulatory Scientist and Project Leader on multiple clinical trials. She obtained her PhD in Immunology and also holds both a Master’s degree and Bachelor’s degree in Biological Engineering.