Studymaker, LLC was founded to provide services and secure web-based tools to researchers so that they could rapidly and cost effectively execute Internet based multi-center studies using electronic data collection forms that are highly secure, HIPAA compliant and adhere to the FDA’s CFR 11 guidelines. The founders recognize there are other electronic data collection vendors in the marketplace, but as active members of the research community themselves, they believe there are unmet needs between the expensive options offered by high-end vendors and what internal IT departments can offer to support study design and deployment.
Studymaker was the outgrowth of work done for a National Institutes of Health Phase 1 and 2 STTR grant by the principal investigator, Dr. Jeffrey A. Kline of the Carolinas HealthCare System and a 20 year veteran software developer, Charles Johnson. Starting in 2003, they collaborated on the development and deployment of a secure web-based system to execute an 8 center study involving the clinical presentation and outcomes of patients treated in the Emergency Department for suspected Pulmonary Embolism. That initial system was described in a publication
“Prospective study of clinician-entered research data in the Emergency Department using an Internet-based system after the HIPAA Privacy Rule.” – BMC Med Inform Decis Mak. 2004 Oct 12;4:17
Studymaker, LLC principals are Dr. Jeffrey Kline, Charles Johnson and Michael Sinsheimer.
Dr. Kline, is an Emergency Medicine faculty member at Carolinas Medical Center, where he also holds the title of Director of Research. He is a well recognized researcher in Emergency Medicine and is on the Board of Directors at the Society of Academic Emergency Medicine.
Mr. Johnson is on staff in the Emergency Department at Beth Israel Medical Center, a Harvard Medical School teaching hospital where he provides informatics support to a variety of researchers for retrospective studies involving clinical data mining and for prospective studies requiring new Clinical Research Forms.
Michael Sinsheimer, the contract administrator for the Company’s founding NIH study is, is the Company’s business manager. He has an MBA from New York University and an MHA from the University of North Carolina. He has 20 years of business management experience in the healthcare field.