CRF Health, a global provider of patient-centered eSource technology and service solutions for the life sciences industry, 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 newly developed 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. Its ability to streamline data collection via an electronic form facilitates the capture of higher quality data and enables fast access to consistent data for further analysis.
A key benefit for sponsors, the new electronic version allows EDSS raters to review and track any inconsistencies in data entries and assessments at the click of a button. Thanks to a unique 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. Furthermore, the electronic Neurostatus-EDSS form was created with in-built explanatory notes and icons designed to assist raters. The need for them to refer to paper-based guidance documents is thereby eliminated, saving valuable time and allowing to focus on the patient and the assessment. 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.”
