Industry’s only electronic Neurostatus-EDSS® System with full scoring algorithms and complete data checks ensures data quality
PHILADELPHIA – May 14, 2018 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today 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 2,000 eCOA clinical trials conducted over 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.”
For more information on how ERT’s eCOA system delivers the highest quality clinical trial data, visit ert.com/eCOA.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2017, more than 60% of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs and CROs have relied on ERT solutions in 13,000+ studies, spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.
About the University Hospital Basel (UHB)
The University Hospital Basel (UHB) is one of five university hospitals in Switzerland and the main hospital for north-west Switzerland. It is a public institution affiliated to the University of Basel, which specializes in the treatment of all patients requiring highly specialized medical care. Research that improves the patients’ quality of life is an important part of the UHB’s mission. The translational focal points of UHB’s research are agreed with the Faculty of Medicine of the University of Basel: immunology, oncology, neurobiology, cell plasticity and tissue repair, biomedical engineering.
Neurostatus-EDSS® is a registered trademark of the University Hospital of Basel, Switzerland.