Durham, NC—January 19, 2021—VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is pleased to announce a new partnership with ActiGraph, a leading provider of medical-grade wearable activity and sleep monitoring devices.

VeraSci’s Innovation Lab will be incorporating ActiGraph’s CentrePoint Insight Watch into an NIH-funded study examining the relationship between real-time measurements of gait and actigraphy collected by industry-grade wearables and established cognitive and functional endpoints that are sensitive to decline early in the Alzheimer’s disease continuum.

Preliminary data have indicated a correlation between remotely captured gait and actigraphy measures and established cognition and function measures. These data suggest that wearables can provide meaningful information regarding cognitive health and may ultimately contribute to continuous assessment of cognition and function in clinical trials.

“Wearables present an incredible opportunity to gather data in ways that haven’t been feasible before. We can gather information directly while patients are engaged in their daily lives” says VeraSci CEO Dr. Rich Keefe, “Our partnership with ActiGraph advances our commitment to pairing scientific knowledge with cutting-edge technology to improve the tools and measurements available in clinical trials.”

“This partnership between ActiGraph and VeraSci provides an exciting opportunity to better understand the relationship between real-world physical behavior, function, and cognition,” said Matt Biggs, ActiGraph’s Head of Business Operations. “We believe that these types of collaborations will help to jumpstart the creation of novel digital endpoints for global health communities.”

Research reported in this release was supported by the National Institute on Aging of the National Institutes of Health Small Business Innovation Research (SBIR) program under Award Number R44AG058345. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies. Learn more at www.verasci.com.

About ActiGraph

ActiGraph is a leading provider of medical-grade physical activity and sleep monitoring solutions for the global scientific community. ActiGraph’s FDA-cleared wearable actigraphy monitors and robust analytics platform have been widely used to quantify human movement in academic and population health research for nearly two decades. In recent years, the company’s monitoring solutions have been steadily adopted by pharmaceutical and life sciences organizations seeking to capture real-world objective outcomes related to physical activity, mobility, and sleep behavior for patients enrolled in clinical trials. For more information, visit www.actigraphcorp.com.

 

Durham, NC—December 18, 2020—VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is concluding a successful year marked by extensive hiring and expanded service offerings. This growth has allowed the company to successfully take on an increasing number of large, global clinical trials. VeraSci has hired 49 new employees in 2020 and added capabilities in remote clinical trials, placebo response mitigation, and wearable devices.

2020 has been a challenging year for companies that provide products and services for clinical trials as COVID-19 delayed or canceled many studies. VeraSci credits its continued success to having quickly adapted to implement remote assessment methods and revise standard methods to allow the safe collection of data. These new innovative solutions prevented delays and cancellations and allowed studies to proceed without missing data.

According to VeraSci CEO Dr. Rich Keefe, “We were able to present our clients with solutions that enabled critical research to continue. Through our expertise and adaptability, we have met the unique challenges that COVID-19 presented for our industry.”

VeraSci expects growth to continue into 2021 having recently been awarded several large phase 3 clinical trials. They are actively recruiting for several open positions to support this growth. Additionally, VeraSci has plans to launch new technology products in the first half of 2021.

“We are proud of our accomplishments this year and believe they position us well for future success,” says VeraSci President Caren Gadigian, “Growing our talent pool and expanding our capabilities allows us to take on larger projects with an extended global reach while maintaining the level of quality and service our clients expect.”

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies.

Neuropsychopharmacology recently published “Placebo Response Mitigation with a Participant-Focused Psychoeducational Procedure: A Randomized, Single-Blind, All Placebo Study in Major Depressive and Psychotic Disorders”. Dr. Bill Horan, Vice President Clinical Science at VeraSci, and VeraSci CEO Dr. Rich Keefe co-authored the publication.

Development programs for CNS disorders face discouragingly low success rates. Placebo response has a potentially devastating impact on CNS trials and has contributed substantially to the late-stage failure of promising treatments. According to the paper, “no empirically-validated participant focused strategies to mitigate the phenomenon have been available.”

The paper presented results from a study evaluating the efficacy of the Placebo-Control Reminder Script (PCRS), a brief script read to participants immediately before administering study assessments. The study demonstrated that participants who received the PCRS reported significantly smaller reductions in depression than those who did not (all participants were receiving placebo).

“This is an important step forward in the development of new drugs for devastating CNS disorders including depression, schizophrenia, and chronic pain,” says Dr. Horan, “A scientifically-backed instrument that reduces placebo response will allow effective treatments to show a positive signal, a necessary step in bringing new treatments to market.”

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies.

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