QuesGen Systems is the Data Management platform for TRACK-TBI. TRACK-TBI sites throughout the United States will enroll 3,000 patients across the spectrum of mild to severe brain injuries. Clinical, imaging, proteomic, genomic and clinical outcome databases will be linked into a shared platform that will promote a model for collaboration among scientists within InTBIR and elsewhere. which was originally funded by the Grand Opportunity Grant (GO study).
TRACK-TBI is built from the foundational NINDS-funded TRACK-TBI Pilot study, which collected clinical data from 3 sites and 600 subjects. With over a dozen publications and growing, the TRACK-TBI Pilot dataset is the first to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository and with the current TRACK-TBI data, is compatible with the International Initiative for Traumatic Brain Injury (InTBIR), a collaborative effort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH).
The global aim of this project is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI. TRACK-TBI also forms one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TEC) Initiative, which has established an interrogatable Metadataset of high quality studies across civilian, sports, and military populations. TED’s goals, aligned with TRACK-TBI, are to identify and validate the FDA regulatory readiness of candidate clinical outcome assessments and proteomic and neuroimaging biomarkers and technologies that may serve as endpoints in the design of precision clinical trials.
QuesGen Systems is located in the San Francisco Bay Area and provides a data management services to clinical investigators, primarily in academic research institutions. The QuesGen platform allows for rapid solution development for a wide variety of clinical research studies. The flexible, web-based platform is HIPAA-compliant and provides an easy-to-use & modify CRF (Case Report Form) environment. QuesGen was selected for several significant Traumatic Brain Injury (TBI) and other neurology-related projects, for which QuesGen developed a large library of electronic Case Report Forms (eCRFs) and neurocognitive assessments.