StudyMaker

Proven Data Tools for Clinical Research

About StudyMaker

StudyMaker, LLC provides services and a web-based electronic data collection (EDC) platform for clinical studies. The StudyMaker EDC web platform is

Proven with both numerous large multi-center and small single site studies
Secure , HIPAA compliant
Cost effective with large library of common eCRF elements
Flexible and Programmable to enhance data capture of unique or complex data series for a study
21 CFR Part 11 compliant. Originally designed to meet all Part 11 requirements.
Empowering with powerful 'Admin' reporting functions for the principal investigator's staff and enrollment dashboard views for the sites.
Turnkey. Investigators send StudyMaker all study documentation including Case Report Form (CRF) specifications. StudyMaker sends back Sign On link to web accessible database. Using it's own proprietary XML based forms description language, StudyMaker provides all the programming services needed to convert case report forms specifications provided into electronic case report (eCRF) s used in the study.

StudyMaker In The news

Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial.

JAMA. 2010 Feb 24;303(8):739-46.

Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators.

CONTEXT: Goal-directed resuscitation for severe sepsis and septic shock has been reported to reduce mortality when applied in the emergency department. OBJECTIVE: To test the hypothesis of noninferiority between lactate clearance and central venous oxygen saturation (ScvO2) as goals of early sepsis resuscitation

Prospective multicenter evaluation of the pulmonary embolism rule-out criteria.

Journal of Thrombosis Haemostasis
2008 May;6(5):772-80. Epub 2008 Mar 3.

Kline1 J.A., Kline1 J.A., Courtney2 D.M., Than3 M.P., Kabrhel4 C., Moore5 C.L., Smithline6 H.A., Plewa7 M.C., McCubbin8 T.R., Richman9 P.B., O’Neil10 B.J., Beam11 D.M., Nordenholz12 K.E., Johnson13 C.L.

BACKGROUND: Over-investigation of low-risk patients with suspected pulmonary embolism (PE) represents a growing problem. ......... RESULTS: We enrolled 8138 patients…...

Nontraumatic Emergency Department Hypotension Predicts Sudden Unexpected In-hospital Mortality

Using the StudyMaker components and programming services, Dr Alan Jones, an Emergency Medicine researcher at Carolinas Medical Center executed a study of out-of-hospital systolic hypotension as an independent risk factor for death. Over the study period of one year, 4,880 patients were enrolled using a TabletPC and the StudyMaker programmed software.

Prospective Study of Clinician-Entered Research Data in the Emergency Department Using an Internet-based System After the HIPAA Privacy Rule

Prospective study of clinician-entered research data in the Emergency Department using an Internet-based system after the HIPAA Privacy Rule