LMK Clinical Research Consulting
Luisa Monica is an experienced Project Manager specializing in Trial Master File (TMF) management, currently working at LMK Clinical Research Consulting since May 2016. Prior to this role, Luisa served as a Project Manager and TMF Business Support Manager at Atrium Staffing on assignment with Pfizer from August 2013 to January 2016, where responsibilities included the retirement of Pfizer's TMF System and archival processes. Luisa's extensive background at Pfizer, spanning over two decades, includes roles in Clinical Trial Process Quality, Vendor Management, Document Management, and Administrative Support. Education includes a High School Diploma from Bayside High School and further studies at Gibbs Business School.
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.