Case Study: Track TBI

//Case Study: Track TBI
Case Study: Track TBI 2018-09-04T20:16:59+00:00


QuesGen Systems, Inc. is a San Francisco Bay Area-based company that provides research services to organizations and investigators, focusing on the development of treatments and diagnostics for Traumatic Brain Injury (TBI) and brain-related diseases. QuesGen’s extensive experience allows the company to quickly execute studies that develop a treatment or diagnostic from concept to market.

QuesGen’s HIPAA-compliant platform facilitates the rapid solution development for a broad range of clinical research studies. Its flexible, web-based design provides an easy-to-use & modify CRF (Case Report Form) environment. With the QuesGen platform you can build electronic forms and questionnaires, conduct data analysis, create HIPAA-compliant custom security profiles, and recruit patients through a custom website that pre-qualifies participants.

QuesGen has developed a large library of electronic Case Report Forms (eCRFs) and neurocognitive assessments for several noteworthy Traumatic Brain Injury (TBI) and other neurology-related projects.

One of these projects is the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI). QuesGen Systems is the Data Management platform chosen for all TRACK-TBI sites across the U.S. that will enroll 3,000 participants with mild to severe brain injuries. All clinical, imaging, proteomic, genomic and clinical outcome databases will be linked directly into a shared platform that will promote collaboration model among International Initiative for Traumatic Brain Injury (InTBIR) researchers and elsewhere. The project was originally funded by the Grand Opportunity Grant (GO Study) and is now supported by the National Institute of Neurological Disorders and Stroke (NINDS).

TRACK-TBI is the result of a NINDS-funded TRACK-TBI Pilot study, which collected clinical data from three sites and 650 individuals. So far, the TRACK-TBI Pilot has originated over a dozen publications (and counting), and its dataset is the first to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository. The project is compatible with the European Commission’s (EC) InTBIR, the Canadian Institute of Health Research (CIHR) and the National Institutes of Health (NIH).

The overall aim of TRACK-TBI is to test and refine Common Data Elements (CDEs), neuroimaging standards and best practices for genetics and proteomics in TBI studies. Researchers expect that this project has the potential to critically advance and revolutionize TBI clinical research. Repositories for neuroimaging, proteomic and genetic biomarkers will be able to facilitate the evolving field of these emerging technologies in TBI.

TRACK-TBI is also one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TED) Initiative, which has established an unquestionable Meta-dataset of high quality studies across civilian, sports and military populations. As with TRACK-TBI, TED’s goals are to identify and validate the U.S. Food and Drug Administration (FDA) regulatory readiness of candidate clinical outcome assessments, for which proteomic and neuroimaging biomarkers and technologies might serve as endpoints in precision clinical trials’ design.

TRACK-TBI is a multi-center prospective observational study for which the University of California, San Francisco (UCSF) is the coordinating center. The UCSF center is led by Geoffrey T. Manley, M.D.: “It has always been a partnership with the QuesGen team. They always go above and beyond to work to help you accomplish your goals,” he stated in a client testimonial.

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