VeraSci Receives FDA Grant to Support Qualification of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that they have received an FDA grant to conduct further research on the VRFCAT, their proprietary functional capacity assessment. The VRFCAT has recently been accepted into the FDA’s COA Qualification Program as a measure of functional capacity for schizophrenia treatment trials. This project will use qualitative research methods to establish the clinical meaningfulness of this measure to patients, family members, and peer support specialists. Qualitative evidence supporting the clinical meaningfulness of the VRFCAT from patient and caregiver perspectives will help advance the VRFCAT through the FDA qualification process and is a key component of interest for payers and health care providers.

The VRFCAT is an eCOA task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, the VRFCAT was developed in VeraSci’s Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

If you are interested in learning more about or demoing the VRFCAT, visit https://verasci.com/vrfcat/.

VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Accepted into the FDA’s Clinical Outcome Assessment (COA) Qualification Program

VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that their proprietary functional capacity assessment, the VRFCAT has officially been accepted into the FDA’s COA Qualification Program. This FDA program is intended to qualify drug development tools that can be relied on to have a specific interpretation and application in any drug development program and regulatory review. VeraSci is in the process of collecting the additional data required to submit a full qualification package to the FDA.

 

The VRFCAT is an eCOA task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, the VRFCAT was developed in VeraSci’s Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

 

If you are interested in learning more about or demoing the VRFCAT, visit https://verasci.com/vrfcat/.

VeraSci Continues Growth Strategy with Hire of Hampton Corley as Chief Commercial Officer

Hampton Corley - Chief Commercial OfficerVeraSci, a leading provider of innovative scientific and technology services, announced today the hire of Hampton Corley, Chief Commercial Officer, to support growth objectives. As clinical trials grow in scope and complexity, VeraSci provides the scientific and operational clarity needed for optimal trial performance and accelerated drug development. Corley spent the last decade in commercial roles at Clinipace during the company’s scale to a global CRO. He joins VeraSci with global experience in the life sciences services industry and will work in conjunction with VeraSci’s team of scientists, global language experts, and Pathway eCOA solutions architects to support pharmaceutical and biotechnology drug development.

“Reference feedback from VeraSci’s existing clients is incredibly compelling,” Hampton said. “Demonstrated trust and focus on customer experience is the recurring theme. And the company is well positioned with scientific service excellence to aid sponsors with their endpoint challenges and speed to signal.”

With the hire, VeraSci will continue their growth momentum and on-going commitment to the principles of scientific integrity and true signal identification in clinical trials research. “Hiring Hampton is part of the expansion that we announced in October when we rebranded the company from NeuroCog Trials to VeraSci,” said Rich Keefe, VeraSci CEO and Co-Founder. “Hampton’s deep and comprehensive experience in life sciences services organizations will bring invaluable strategic expertise to VeraSci as we continue to grow.”

VeraSci Welcomes William P. Horan, PhD as VP of Clinical Science

William P. Horan, PhD VeraSci, a leading provider of innovative scientific and technology services, announced today that William P. Horan, PhD will join the company as Vice President of Clinical Science. In this role, Dr. Horan will use his expertise in cognition, clinical neuroscience, and symptom assessment to provide scientific and operational support for clinical trials in psychiatric disorders.

Over the past 20 years, Dr. Horan’s clinical research has focused on understanding and developing treatments for motivational, social cognitive, and neurocognitive disturbances that impact functional outcomes in schizophrenia and other neuropsychiatric conditions. Specific interests include negative symptoms, translational affective and social cognitive neuroscience, reward processing, effort-based decision making, and development of novel physiological and behavioral tasks for use as endpoints in clinical trials.

Dr. Horan is well respected in the schizophrenia research community. His research has been funded by NIMH, VA, and foundation grants, and he served as a Principal Investigator in the NIMH Collaboration to Advance Negative Symptom Assessment in Schizophrenia.  “We are thrilled to have Dr. Horan joining our team of world-class scientists joining the effort to bring life-changing treatments to people with CNS disorders,” said VeraSci CEO Dr. Richard Keefe. “Dr. Horan has been pushing innovative assessments and treatment strategies for a variety of different conditions for two solid decades, and his experience and expertise will contribute immediately to our unique capacity for thought partnership.”

Prior to joining VeraSci, Dr. Horan was Professor-in-Residence in the Department of Psychiatry & Biobehavioral Sciences at UCLA and Chief of the Psychosis Section at the VA Greater Los Angeles Healthcare System. He also serves on the Editorial Boards of Schizophrenia Bulletin, Schizophrenia Research: Cognition, and Journal of Abnormal Psychology (Associate Editor). He has over 130 peer-reviewed articles and has been recognized as a Thomson Reuters Highly Cited Researcher (Top 1% in Psychiatry/ Psychology).

Leading Provider of Innovative Scientific and Technology Services Welcomes Mark Skeen, MD as Senior Medical Scientist

Mark Skeen, MD as Senior Medical ScientistVeraSci recently welcomed Mark Skeen, MD as Senior Medical Scientist. In this role Dr. Skeen will provide disease state expertise for a broad range of neurologic diseases as well as the perspective of the clinician conducting clinical trials. As part of his role at VeraSci, he will assist in the implementation of the trials of both relapsing and progressive forms of multiple sclerosis (MS).

Dr. Skeen officially joined VeraSci after assisting with the development of the Multiple Sclerosis Individual Outcome Assessment (MSIOA), a structured interview designed to address the need for a patient-centric account of MS symptoms throughout the course of a clinical trial, and an eCOA version of the Neurostatus EDSS. Both of these tools are based in Pathway, VeraSci’s eCOA Platform.

Dr. Skeen brings with him over three decades of clinical experience from general internal medicine to neurology subspecialty care. For the past 15 years, his focus has been on multiple sclerosis and related autoimmune conditions. He is board certified in Internal Medicine, Neurology, and Clinical Neurophysiology and has broad clinical experience in neurology clinical trials in several disease states.

Dr. Skeen is recognized as a thought leader in MS and has been recognized for both clinical and research expertise. “We are delighted to have Mark join our team at VeraSci,” said VeraSci CEO Richard Keefe. “Given the explosion of new mechanisms of action in MS and other neurologic conditions, we are excited to have a tremendously accomplished and knowledgeable leader to provide expertise in this area of work and help round out VeraSci’s team of scientific partners to industry research trials.”

Dr. Skeen also serves as an Associate Professor of Neurology at Duke University Medical Center and is the head of the division of MS and Neuroimmunology. He is a Fellow of the American College of Physicians and the American Academy of Neurology. Dr. Skeen has many longstanding partnerships throughout the pharmaceutical industry and brings a distinctly clinical neurologic perspective to VeraSci.

Significant Enhancements Announced for Pathway, VeraSci’s Proprietary eCOA Platform

Significant Enhancements Announced for Pathway,

VeraSci’s Proprietary eCOA Platform

Integrating Clinical, Cognitive and Functional Assessments onto one device.

 

Durham, NC—December 6, 2018—VeraSci, a global clinical technology and research services company, announces multiple significant enhancements to Pathway, their proprietary eCOA platform. Pathway, which reinvented how raters, sponsors and site administrators conduct assessments and scales for clinical trials, now offers enhanced data collection and administration, and access to a larger number and type of scales and assessments.

The Pathway team worked with raters, scale-developers, and sponsors to ensure that all Pathway users would derive optimal functionality while accommodating the needs of each study and site. The improved flexibility of Pathway allows for the use of a single device for multiple assessments and multiple protocols, permits high enrolling sites to use different devices for parallel assessment of multiple patients, and easily integrates all of the data. VeraSci’s proprietary assessments, BAC and VRFCAT, and licensed gold standard endpoints and safety measures for multiple therapeutic areas such as the EDSS and C-SSRS, are now accessible through a single Pathway-enabled device. In addition, raters can administer assessments on Pathway and obtain consent from test subjects on the same device.

Available in multiple languages, Pathway is able to accommodate a sponsor’s specific needs for an integrated experience in a variety of countries, with negligible failure rates or device issues. VeraSci’s multi-lingual tech support teams in Europe, Asia, and the United States provide support in sites’ local languages, and VeraSci’s Global Language Solutions team provides scientifically valid translations and cultural adaptations of required assessments.

The feedback from users has been extraordinary. Dave Walling, Ph.D. of CNS Network LLC, explains, “Pathway simplifies the process for raters at the site level by integrating the assessments into one system. Rating on a tablet can often be a frustrating experience as there are multiple log-ins, connection problems, and technological mishaps…Pathway helps to combat those issues and makes the process easier for staff, subjects and ultimately, sponsors”.

If you are interested in learning more about Pathway, an FDA 21 CFR Part 11 Compliant eCOA platform, visit our website; https://verasci.com/what-we-do/our-solutions/pathway/

About VeraSci

Founded in 2004, VeraSci has a worldwide presence in clinical trial development, clinical and cognitive assessment and language services. VeraSci brings deep expertise, strategic innovation and unwavering commitment to every project, allowing each client to deliver data supporting innovative therapies.

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VeraSci is a registered trademark of NCT Holdings in the United States and/or other countries.