Plymouth Meeting, PA – 10 July 2017: CRF Health, a global provider of patient-centered eSource technology and service solutions for the life sciences industry, announced that it has collaborated with a research group led by Professor Ludwig Kappos at the University Hospital Basel (UHB) to develop an electronic implementation of the Neurostatus-Expanded Disability Status Scale (Neurostatus-EDSS), an established assessment and documentation tool for Multiple Sclerosis (MS) clinical trials.
The electronic version of the Neurostatus-EDSS replaces the traditional paper forms which suffer from the typical associated issues, such as data inaccuracies and administration costs. It streamlines data collection via an electronic form, facilitates the capture of data, and allows for access to consistent data for further analysis.
The new electronic version allows EDSS raters to review and track any inconsistencies in data entries and assessments at the click of a button. Due to an algorithm created by the UHB, which identifies inconsistencies within data, the EDSS rater can reconsider her/his scoring. In case of remaining doubts, the EDSS rater can communicate with an expert team at the UHB. The Neurostatus-EDSS form along with the expert and rater interaction during the review process is all completed in the CRF Health TrialManager environment and all comments and score changes are fully audit trailed.
Commenting on the development, Rachael Wyllie, Chief Executive Officer at CRF Health said, “With the form already utilized in a number of clinical studies, the introduction of the electronic Neurostatus-EDSS documentation tool will facilitate much improved data collection for potential drugs for neurological conditions and significantly speed up the development process. CRF Health has recently provided the eCOA technology platform which supported a top global pharmaceutical company in gaining FDA approval for an MS drug. This latest development further cements our position as a leader in this field.”
Dr. Marcus D’Souza, Neurologist and Head of Neurostatus-UHB at the UHB, commented: “We are delighted to have collaborated with CRF Health on this project to help create this electronic Neurostatus-EDSS assessment and documentation tool and are very much looking forward to seeing sponsors reap the benefits this new form promises for neurological clinical trials.”
For further information on CRF Health, please visit www.crfhealth.com
Contact: media@crfhealth.com, +1 267.498.2350
Neurostatus-uhbs@usb.ch
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.