ERT, a global data and technology company that minimises uncertainty and risk in clinical trials, has announced the availability of the ERT Neurostatus-EDSS System.
The complete electronic clinician-reported outcome (eClinRO) assessment solution delivers high quality data from the Neurostatus-Expanded Disability Status Score (Neurostatus-EDSS), a widely used primary outcome measure that is accepted as a basis for labeling claims in multiple sclerosis (MS) clinical trials.
Produced in collaboration with Neurostatus-UHB ─ a research group led by Professor Ludwig Kappos at the University Hospital Basel (UHB) ─ ERT will provide the electronic Neurostatus-EDSS, which is currently the industry’s only version to include full scoring algorithms and complete edit checks from the original Neurostatus-EDSS.
As a result, data discrepancies are reduced, as is the burden of data verification and query resolution typically placed on site raters, UHB expert reviewers, and trial sponsors.
“ERT truly understands the importance of maintaining the scientific properties that are critical to capturing valid Neurostatus-EDSS data,” said Marcus D’Souza, MD, Neurologist and Head of Neurostatus-UHB at the University Hospital Basel.
“We’re pleased to have collaborated with them in the development of a complete electronic solution that ensures the reliability of this important data for MS researchers.”
Based on best practices gleaned from more than 2000 eCOA clinical trials conducted during the past 20 years, ERT designed this electronic Neurostatus-EDSS system under the guidance of Neurostatus-UHB.
ERT is the first eCOA provider to collaborate with Neurostatus-UHB on a complete electronic Neurostatus-EDSS system that includes the full scoring algorithms and complete edit checks from the original Neurostatus-EDSS.
These algorithms and edit checks allow clinician raters to review and address data inconsistencies in real-time, improving MS clinical trial data quality.
From training investigative site raters to effectively capturing the Neurostatus-EDSS electronically, to enabling clinical data query resolution via an interface with UHB central reviewers, sponsors can improve data quality while significantly improving MS trial efficiencies.
“We worked very closely with Dr D’Souza and his team to ensure the ERT Neurostatus-EDSS system meets the high standards of data reliability set by UHB,” said Susan M. Dallabrida, PhD, Vice President of eCOA Clinical Science and Consulting at ERT.
“We’re delighted to provide a means for trial sponsors to collect high quality data and to confidently accelerate development of new MS treatments for the patients who need them.”