TRACK-TBI and QuesGen: A Decade of Life-Changing Database Management

CASE STUDY: TRACK-TBI partnered with QuesGen for its complex database management needs.

More Than a Database

For more than 10 years, TRACK-TBI and QuesGen have partnered to find a solution to a major public health problem – while changing the future of medicine along the way.


QuesGen has worked with TRACK-TBI since 2010.


Over 3,700 patients have been enrolled in this study.


18 data collection sites throughout the U.S.

TRACK-TBI has been able to use their core functionality designed by QuesGen for new leveraged specialty investigations.

Executive Summary

For more than 10 years, TRACK-TBI and QuesGen have worked together with the goal of advancing and revolutionizing clinical TBI research. TRACK-TBI is one of the largest studies in the world seeking to better understand the long-term impacts of traumatic brain injuries.

An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, but research can become rather complex with the data management side of the equation because there are so many influencing factors and data points that are needed over a long period of time in order to accurately capture, analyze, and study the numbers.

TRACK-TBI’s main goal is to build the fully integrated TBI Information Commons and provide a global platform to connect TBI’s best scientists, which puts QuesGen at the core of TRACK-TBI’s purpose. The outcome for this international resource is to identify new diagnostic and prognostic markers (including neuroimaging, proteomic, and genetic biomarkers) and refine outcome assessments.

TRACK-TBI also forms one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TED) Initiative, which has established a metadata set of high-quality studies across civilian, sports, and military populations.

The Department of Defense 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.

    To make progress on this critical mission, TRACK-TBI needed a partner they could trust to quickly and effectively deliver a data management and research system equipped to handle a growing complex set of data.

    QuesGen’s Role:

    • Develop a fully integrated TBI data management and research platform to connect the best scientists in the field of brain health for the TRACK-TBI study
    • Develop Electronic Case Report Forms (eCRFs) supporting various protocols
    • Provide secure and available web-based data systems and storage
    • Use the centralized data platform to provide validation and curation to drive data integrity for the study
    Download a PDF of this case study!

    Project Goals

    Improve TBI classification/taxonomy for targeted clinical treatment trials 
    Improve TBI outcome assessments, such that the size and costs of clinical trials can be reduced 
    Identify the health and economic impact of Mild TBI patient disposition 
    Create a legacy database with analytic tools and resources to support TBI research 

    The Need for Speed and Flexibility 

    TRACK-TBI was looking for a partner who could not only manage the data but would excel at the communication and service side of things as well. They had worked with other companies in the past that did not deliver on time and with poor user interfaces. Faced with a tight deadline to meet the requirements of their grant, TRACK-TBI couldn’t risk that experience again and needed the right partner to step up.

    “We had interacted with QuesGen through a mutual colleague and suspected they could do a better job. In fact, they (QuesGen) did.” – Geoffrey T. Manley, MD, PhD

    TRACK-TBI summarized QuesGen’s high-touch service and support in three words: speed, quality, and understanding. After more than a decade of partnering on these complex initiatives, TRACK-TBI knows QuesGen will deliver on time, at the quality they require, and with a deep understanding of their work.


    “They’ve taken the time to get to know what we do. They are more than a database. It’s not just a business transaction for them…they really care about this major public health problem we are trying to solve.”

    Geoffrey T. Manley, MD, PhD

    Less Administration Work, More Science

    TRACK-TBI’s data was complex, and they were trying to see how much data was feasible to collect. The simple data structures they tried to use in other systems before QuesGen didn’t work; TRACK-TBI’s complex data didn’t fit. They also needed to concentrate on the science aspects of their study and less on the administration.

    TRACK-TBI knew QuesGen had the expertise and nimbleness to help and adapt to their unique needs.

    As previously mentioned, the nature of this initial “go grant” placed a tight deadline on TRACK-TBI and QuesGen. They had a mere three months to get the study up and running. For many research data professionals, this poses a challenge. In this case, however, TRACK-TBI was able to successfully move forward thanks to QuesGen’s ease of design and the ability to quickly develop the system focused on their needs. Everything was able to be deployed in a matter of weeks and refined over those months for a smooth launch.

    Building a Decade of TBI/Brain Health Expertise

    The QuesGen platform has evolved a lot since those early years with TRACK-TBI, including several spinoffs based on the TRACK-TBI database learnings.

    For any brain health study, whether it’s a multi-site model or otherwise, QuesGen is light years ahead of its competitors with unmatched experience in complex data structures – especially in the area of brain health.

    With over 3,700 participants enrolled in this study – from adults and children with traumatic brain injuries to orthopedic controls, friend and family controls, and patients obtaining advanced neuro imaging – the protocols in TRACK-TBI are varied based on the cohort. However, the accuracy and dependability of the data remain unchanged.

    To learn more about TRACK-TBI and their goal to effectively diagnose, categorize, and treat traumatic brain injury, visit:

    “QuesGen has been our go-to platform for all of our observational studies to date. We have a long-standing relationship with them. It’s a very good relationship.”

    Geoffrey T. Manley, MD, PhD

    About the Principal Investigator

    Dr. Geoffrey T. Manley, MD, PhD is the Contact Principal Investigator for TRACK-TBI and a close partner of QuesGen throughout these 10+ years. An internationally recognized neurosurgeon and expert in neurotrauma, he has published more than 280 manuscripts that reflect a wide range of research interests, from molecular aspects of brain injury to the clinical care of head trauma patients.

    Dr. Manley has helped to define new molecular mechanisms of injury to the nervous system that may lead to new treatments for these devastating injuries. He is also considered a leader in the rapidly growing field of advanced neuromonitoring and clinical informatics for critical care.

    An Ideal Research Partner

    Book a call with our team to review resources and learn more about our data management platform and suite of services, or call 650-777-7617.