LMK Clinical Research Consulting
Sophie Fitzhugh is a seasoned professional in clinical research, currently serving as a Senior Project Manager and TMF Project Manager at LMK Clinical Research Consulting since July 2020. Sophie's responsibilities include developing and implementing Trial Master File (TMF) specifications and providing clients with TMF expertise. Previously, Sophie held roles at Takeda from June 2019 to June 2020 as a Clinical Trial Associate, overseeing clinical studies and managing study-related issues, while also conducting quality control for TMF documents. Earlier experience includes an internship at Shire as a Clinical Study Support Intern, where communication with study teams and ensuring timely delivery of study documents were key functions. Sophie graduated from Miami University in 2019 with a Bachelor of Arts in Psychology.
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LMK Clinical Research Consulting
Inspection Readiness. Two words that can ignite worry, fear, and stress. At LMK, we work with our clients to alleviate those concerns and ensure that you are inspection ready from Day One. We believe that the clinical trial content is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. LMK takes a proactive approach and makes clinical trial content quality a top priority on an ongoing basis - from start through closeout - not just pending an inspection or trial completion. Don't let your content be a collection burden at the end of a trial! It is a management tool throughout the life of your trial. LMK can help you plan, collect, and maintain your clinical trial content cost effectively without jeopardizing quality. We offer our clients a combination of expertise, tools, processes, and extensive knowledge of the clinical drug development process. Our experts will assess your study requirements and processes and create a plan customized to meet your specific needs. LMK is a division of TransPerfect Life Sciences. TransPerfect Life Sciences provides a full suite of e-clinical, product development, language, and technology solutions to our clients. From idea to launch, we help you every step of the way.