LT Quality Consulting was founded in 2022 by L.Thomas. Having started in the clinical research industry in the early 2000’s, she’s had a rewardingly progressive career in the industry. She immediately grew a passion for quality and ethical research, and these became underlying principles in the approach to all of her roles - from data management and quality control, to managing Quality Assurance for high-profile client portfolios.
Birthing LT Quality Consulting started as a shift of work-life balance, and has developed into much more. Over a decade of auditing experience identified opportunities to provide services beyond sponsor/CRO clients. As the company's founder and Principal Consultant, she is excited to offer consulting support to sponsor clients as well as investigator sites.
Our Principal Consultant's GCP expertise encompasses more than 16 years of clinical research industry experience across investigator site, CRO, and QA consultancy; this includes more than 200 GCP audits conducted, including vendor, study compliance, investigator site/CRO, qualification, and process focused; and more than 10 US FDA inspections hosted at investigator site and CRO levels. Trial experience includes phase 1 (including First-in-Human dosing) and various therapeutic areas in phases 2-4, advanced therapies including CAR-T cell, and non-interventional studies. The Principal Consultant is also skilled in QMS review, CAPA development/review, and source document writing.
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