VeraSci, a leading provider of innovative scientific and technology services, announced today the expansion of their proprietary eCOA platform to fully integrate the Neurostatus-EDSS assessment and Neurostatus data clarification services for MS trials. VeraSci partnered with Dr. Marcus D’Souza and Prof. Ludwig Kappos at Neurostatus-UHB, University Hospital Basel, in the implementation of this digital scale intended for use in Multiple Sclerosis (MS) clinical trials.

“The VeraSci eCOA EDSS provides MS researchers with a set of extraordinary advantages in assessing EDSS. Personally, I love the interface, and I can’t wait to see the quality of data generated by this innovative tool. I recommend everyone have the chance to experience it for themselves,” said Dr. D’Souza.

The Neurostatus-EDSS assesses and monitors levels of disability over time, and is considered an essential endpoint for clinical trials in MS. It is comprised of a comprehensive neurological exam and scoring system that assesses seven Functional Systems and Ambulation to provide a final EDSS step score that depicts level of disability from MS.

VeraSci has designed the eCOA Pathway to provide a superior data collection experience for the rater.  We have significantly improved cross rater scoring consistency through the implementation of the Neurostatus EDSS Algorithm. To further drive rater consistency and improved data quality, VeraSci has enabled Neurostatus consultants to be directly integrated into the Pathway data clarification process and work directly with the sites to resolve data inconsistencies immediately.

When asked what impact this tool would have on MS clinical trials, Mark Skeen, MD,  Senior Medical Scientist at VeraSci and Associate Professor of Neurology at Duke University Medical Center explained, “The VeraSci Pathway Neurostatus-EDSS improves the examiner’s ability to easily and accurately document Neurostatus-EDSS in the setting of clinical trials. The result is ease of use, better data acquisition and reduced overhead for clinical trials in Multiple Sclerosis.”

If you are interested in learning more about VeraSci’s Neurostatus-EDSS, visit https://verasci.com/neurostatus-edss/

“Inconsistent Movement Disorders Society-Unified Parkinson’s Disease Rating Scale Part III Ratings in the Parkinson’s Progression Marker Initiative” co-authored by VeraSci expert Dr. Travis Turner was recently published in Movement Disorders. The Parkinson’s Progression Markers Initiative (PPMI) study looked at the ratings of Part III of the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) performed by site investigators trained by online training. The study identified likely errors resulting from transcription and data entry and suggests that employing a direct data capture method like eCOA could result in higher quality data.

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The European Review for Medical and Pharmacological Sciences recently published “Impact of reimbursement limits on patient access to direct-acting antivirals in Italy: analysis of data from national registries” co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. The study looked at patients in Italy with Hepatitis C treated with Direct Antiviral Agents (DAA) when Dr. Pani was the Director General of the Italian Medicines Agency (2011-2016) and after that (2017-2018).

The World Health Organization has called to eliminate Hepatitis C based on the efficacy and safety of DAA therapy. As a result, Italy adjusted its reimbursement practice in 2017. From 2015 until the change in 2017, DAA therapy was reimbursed only for patients with advanced Hepatitis C. This changed in 2017 when universal access to DAA therapy was granted. The study examined patient recruitment trends with and without limitations to access to DAA therapy. The study found that removing limits on reimbursement impacted the types of patients treated but did not significantly change progress towards disease elimination highiligting the importance of including the ability of modern healthcare systems to deploy innovative medications to patients in need. Read the full article here.

Learn more about VeraSci’s HEOR capabilities

Vital Transformation, a consultancy focused on addressing the challenges of modern healthcare systems, recently reviewed country-level COVID-19 data to determine the impact of widespread testing on both the spread of COVID-19 and the economic impact of COVID-19. Their results showed that countries that pursued a strategy of aggressive testing were more successful at managing the spread of the disease and are likely to suffer less economic impact. Dr. Luca Pani, VeraSci VP of Regulatory Strategy and Market Access Innovation collaborated on the review.

Results are published on the Vital Transformation website.

 

 

Last week, the Journal of Translational Medicine published a report on the increase in R&D productivity in the industry. The article published the results of analyses of pharmaceutical industry data for the past decade. Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation was a co-author of the paper.

The authors analyzed data from more than 50,000 pharmaceutical projects spanning 27 years alongside data on sales, patents, and institutional involvement. The analyses identified several significant findings:

  • A trend towards high uncertainty/high potential indications such as oncology
  • Attrition rates are decreasing at all stages of clinical development
  • The time to identify projects to discontinue is decreasing
  • The number of projects focused on advanced therapies is growing
  • Biotech companies have reached a level of productivity on par with large pharmaceutical companies

Read the full article here.

VeraSci is taking all appropriate measures to ensure business continuity and employee health and safety. The governments of the United States and the state of North Carolina have declared a state of emergency, and NC has issued a stay-at-home order effective through April 30.

Since Monday, March 16th, most VeraSci employees have been working from home. We have been utilizing our recently established technology and processes to continue delivering the high levels of service and quality our clients expect, without fail. Our employees have been doing a commendable job supporting each of our clients during these unprecedented conditions. We are fully confident that we will continue delivering a high level of service to all clients throughout the pandemic.

Our shipping department has noted that a few countries are experiencing shipping delays. These delays have no impact on current study deadlines. We will continue to monitor them for all studies. Any new issues noted for your study will be promptly communicated to you by our project team.

While travel to some global locations is not currently possible or recommended, this has not impacted any of our contractual commitments. We will continue to provide updates through our website and social media channels as the situation progresses.

Please reach out to us or any member of your project team if you have questions or concerns.

Richard Keefe, Ph.D. CEO
Caren Gadigian, President