Burlingame, CA (PRWEB) March 03, 2016
San Francisco Bay Area’s QuesGen Systems to attend and participate in the FDA’s TBI workshop this week. The focus of the workshop is to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI).
The aim of the workshop is to obtain input from the scientific, clinical, patient and regulatory considerations associated with TBI biomarker development to improve diagnostic and clinical utility for TBI. Establishing biomarkers for TBI has the potential to improve diagnostic capabilities, understand and monitor the pathological processes involved, and target treatment in clinical trials to support development and approval of medical products. This workshop seeks to address the evidentiary gaps and challenges associated with biomarker development in order for their utilization to increase the innovation of medical products for TBI.
QuesGen Systems, Inc. (http://www.quesgen.com) provides data management and study resources to organizations, with the primary focus on TBI and brain health. QuesGen is working with Track-TBI (11 medical centers across the US), CENTER-TBI (72 centers across Europe), CENTER-TBI/China (40 centers in China), CARE (Prospective TBI study in 30,000 college athletes) and many others.
For more information about QuesGen Systems, please contact Barbara Maley, 650-727-0611; email: barbara.maley(at)quesgen(dot)com