The proprietary platform (eCOA Pathway; VeraSci, Durham, NC) has been expanded to fully integrate the Expanded Disability Status Scale (EDSS) assessment and Neurostatus data clarification services for MS trials. VeraSci partnered with Dr. Marcus D'Souza and professor Ludwig Kappos at Neurostatus-UHB, University Hospital Basel to implement digitization of the EDSS. The intended use is for multiple sclerosis (MS) clinical trials.
The Neurostatus-EDSS assesses and monitors levels of disability over time, and is considered an essential endpoint for clinical trials in MS. It is comprised of a comprehensive neurologic exam and scoring system that assesses 7 functional systems and ambulation to provide a final EDSS step score that depicts level of disability from MS.
The platform was designed to provide a superior data collection experience for the rater. The rater scoring consistency greatly improved through the implementation of the Neurostatus EDSS algorithm. To further drive rater consistency and improved data quality, Neurostatus consultants were directly integrated into the data clarification process and work directly with tsites to resolve data inconsistencies immediately.
"The VeraSci eCOA EDSS provides MS researchers with a set of extraordinary advantages in assessing EDSS. Personally, I love the interface, and I can't wait to see the quality of data generated by this innovative tool. I recommend everyone have the chance to experience it for themselves," said Dr. D'Souza.
Farhat Husain, MD; Divya Singhal, MD; and Sergio Ramirez Salazar, MD
Rachana Gandhi Mehta, MD; Vanessa Baute Penry, MD; and Herbert Lloyd Bonkovsky, MD
Stefan Nicolau, MD, and Elie Naddaf, MD