SABER takes great pride in being a flexible and adaptable research partner. No two studies have exactly the same needs, and the ability for any system, in particular a data capture system, to allow for multiple approaches is essential to a project’s success.
REDCap Cloud has helped us to provide effective solutions to novel challenges faced by our studies, enabling us to adjust to new parameters.
Overview
The University of Michigan’s Statistical Analysis of Biomedical and Educational Research Group (SABER) unit of the Department of Biostatistics provides expertise in the design, conduct, and analysis of multi-center clinical trials and multi-disciplinary research. SABER applies its resources to deliver time-effective design and quality-based output to meet investigational needs, whether they be statistical, methodological, or operational.
SABER supports clinical research in a variety of different disease states for investigators inside and outside of the university, ranging from single-center clinical trials that span a few dozen patients to international studies targeting thousands of participants. That includes trials of new therapies, as well as observational natural history registries, and research consortia brought together to develop new studies, in areas including pulmonary, nephrology, diabetes, cardiology, and many others.
Among the projects supported by REDCap Cloud, DEPTH (Doxycycline for Emphysema in People Living with HIV) is a phase 2, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Sponsored by the National Heart, Lung, and Blood Institute (NHLBI), the study aims to determine if doxycycline reduces progression of emphysema relative to placebo as measured by rate of decline (slope) of present predicted diffusing capacity for carbon monoxide corrected for hemoglobin, carboxyhemoglobin, and barometric pressure over the 72-week treatment period. SABER is the data coordinating center for this project and will provide project management, data management, clinical monitoring, software development and statistical analysis for the clinical trial.
SABER Group and REDCap Cloud
SABER Group selected the REDCap Cloud platform as its electronic data capture (EDC) system for all of the new studies it’s launching, after searching for a 21 CFR Part 11-compliant EDC system to replace one being sunset by the university.
REDCap Cloud’s robust functionality, ease of use by non-programmer staff, and patient portal enabling direct participant feedback were all factors in the selection.
Business impact
Easier deployment and maintenance of clinical studies
Offers a robust base for traditional studies, while facilitating decentralized and hybrid clinical trial models
Patient portal option enables trials that weren’t feasible under the prior EDC system
Dashboard for clinical trial sponsors enables real-time data monitoring without the need for additional reports
Robust and secure data management solutions with the flexibility to be tailored to individual study needs
