VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that their proprietary functional capacity assessment, the VRFCAT has officially been accepted into the FDA’s COA Qualification Program. This FDA program is intended to qualify drug development tools that can be relied on to have a specific interpretation and application in any drug development program and regulatory review. VeraSci is in the process of collecting the additional data required to submit a full qualification package to the FDA.
The VRFCAT is an eCOA task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, the VRFCAT was developed in VeraSci’s Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.
If you are interested in learning more about or demoing the VRFCAT, visit https://verasci.com/vrfcat/.