MICHR Introduces “Mi-OC” Do-It-Yourself Version Of OpenClinica Clinical Trial Management Software

Press Release | Mi-OC (University of Michigan OpenClinica) | September 17, 2012

The Michigan Institute for Clinical & Health Research (MICHR) has introduced a new version of OpenClinica clinical trial management software. Mi-OC (University of Michigan OpenClinica) has the same features and functionality as the previously released edition, but allows researchers a "do-it-yourself" option.

MICHR began offering V-OC (Validated OpenClinica) in the fall of 2011 for clinical trial databases. This version is fully compliant with FDA regulations for studies that are intended to be used for FDA submissions and requires research teams to partner with MICHR experts to build and manage study databases. With the introduction of Mi-OC, researchers can now build and manage their clinical study databases themselves, after receiving free training from MICHR.

“OpenClinica’s electronic data capture and clinical data management system is now within easier reach of investigators with Mi-OC,” said Mary Phelps, Associate Managing Director, MICHR. ”It is free, secure, and has robust features including discrepancy management, source data verification, and reusability of study report forms.”

MICHR also continues to offer REDCap – the easy-to-use, no-cost, secure, HIPAA-compliant, web-based application – for simple, do-it-yourself data capture and data management, and recommends Mi-OC for studies requiring more complex databases that require data management functionality. MICHR recommends V-OC for more complex studies requiring compliance with federal regulations.

For more information on OpenClinica and other clinical research enabling solutions, contact MICHR at 734.998.7474 or um-michr@umich.edu to schedule a consultation.