"We've worked together for a number of years on complex projects ranging from rescue studies to risk assessment to BIMO inspections. One of the top quality professionals I have worked with as there is an important balance of in-depth knowledge of the regulations with realistic solutions for the situation. '' Vice President, Clinical Affairs

"An excellent Clinical Quality resource; someone to be relied on. Poised and confident face for the sponsor organization with FDA BIMO inspectors during inspection. Ensures ongoing organizational compliance by staying up to date on regulatory agency thinking." Vice President of Advanced Product Development and Interim Vice President of Quality

"Spearheaded the development and implementation of our clinical training program. Expansive knowledge in SOP and document development, accompanied by intrinsic attention to detail. Provided a solid foundation for our training program that our company can continue to grow with." Clinical Project Manager

"Consummate QA and Compliance professional who understands how the different facets of QA and compliance affect clinical operations and provides compliance advice appropriate to the varying situations. Audits are thorough and reports are comprehensive. Well versed in the management of clinical QA operations." Principal Specialist, Clinical Quality Assurance and Compliance

"Comprehensive GCP knowledge. Quick and competent work. Experienced and perceptive; prioritizes so that the small stuff stays small and the big stuff is brought to your attention." Associate Director, Medical Writing

"Working  together has truly strengthened my interpretation of ICH-GCP quality guidelines. The mentorship and training that was provided was consistently thorough on various aspects of clinical activities, including audit readiness for the Trial Master File (TMF)." Clinical Trial Associate