CRF Health creates electronic forms for MS clinical trials
The eSource technology and service solutions provider collaborated with a research group at the University Hospital Basel (UHB) to develop an electronic implementation of the Neurostatus-Expanded Disability Status Scale (Neurostatus-EDSS).
The electronic version replaces traditional paper forms and offers several benefits, according to the company, which noted data inaccuracies and administration costs associated with paper forms.
“Completing the EDSS electronically streamlines the collaboration between the neurologists who do the primary assessment and expert reviewers who review all EDDS assessments and provide feedback if needed,” Rauha Tulkki-Wilke, VP, Product and Service Management, CRF Health told us.
The new form has been used in a number of clinical studies, CRF Health's CEO noted in the company's release.
“As these studies are global, capturing the forms electronically, enables the team to do their parts of the process without waiting for paper forms to be shipped between the sites and the expert centers, which speeds up the process of completing the assessments,” added Tulkki-Wilke.
Additionally, UHB created an algorithm that identifies inconsistencies within the data. The form also features in-built explanatory notes and icons designed to assist raters.
The EDSS is a complicated instrument, Tulkki-Wilke explained, due to the algorithm and the expert review process. CRF Health solved the challenge by working closely with study sponsors and the University of Basel, “each bringing to the discussion their expertise from scientific, clinical and technical fields,” she said.
The Neurostatus-EDSS form is all completed in the CRF Health TrialManager environment – CRF Health’s online portal that enables companies to monitor and manage eCOA clinical trial data in real-time.
