This week, Nature Medicine published results from an innovative trial in anhedonia. Anhedonia, or lack of pleasure, is a key symptom in a number of mood and anxiety disorders including depression. VeraSci experts Dr. Rich Keefe, CEO, and Trina Walker, VP Clinical Assessments, were collaborators on this study funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH). The trial demonstrated that the kappa opioid receptor (KOR) is a potential target for new treatments for anhedonia. The innovative fast-fail approach utilized by the trial allows researchers to assess whether targeting a particular biological mechanism will have the desired effect. Clinical trials in CNS disorders have a notoriously low success rate, and this fast-fail approach has the potential to improve efficiency and decrease the cost of developing new treatments for CNS disorders.

VeraSci is taking all appropriate measures to ensure our staff are prepared to continue business operations over the next several weeks. The governments of the United States and our state of North Carolina have declared a state of emergency and have encouraged businesses to allow employees to work from home.

Beginning Monday, March 16th most VeraSci employees will be working from home. We have assured that we have the technology and processes in place to continue delivering the high levels of service and quality our clients expect. We have utilized these processes in the past during major weather events, and we are confident that our services will continue as normal.

Our shipping department has noted that a few countries are experiencing shipping delays. This has no impact on current study deadlines. We will continue to monitor this 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

We wanted to inform you on VeraSci’s current response and policy formation regarding COVID-19, the coronavirus. VeraSci’s office is currently open. We are taking all appropriate measures to ensure our staff are prepared to continue business operations over the next several weeks.

North Carolina has declared a state of emergency and cases of the virus have been confirmed in our state. We want to assure you that even if we decide to close our office we have the necessary procedures and plans in place to ensure that all business operations will continue.

If a decision is made to close the office, VeraSci staff will follow our normal Business Continuity and Disaster Recovery Plan. This plan includes provisions that allow staff to work from home. We have utilized these processes in the past when we have had major weather events (e.g. snow/ice) so we are confident that our services will continue as normal even if employees need to work remotely.

Our shipping department has noted that a few countries are experiencing shipping delays. This has no impact on current study deadlines but VeraSci will continue to monitor this 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 had a direct impact on any of our contractual commitments.

VeraSci management will continue to monitor the status of the virus and adjust our business processes as needed. We will send updates to all sponsors if our office closes or if any major modifications to our business commitments are required.

We are available to answer any questions or concerns you have about this information.

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

The Lancet Digital Health published the article “A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD); a randomized controlled trial” on Monday, February 24. VeraSci CEO Dr. Rich Keefe was a co-author on this article. The article shares the results of a pivotal study for AKL-T01, an investigational digital therapeutic that targets attention and cognitive control through a video game-like interface. The digital intervention was shown to significantly improve performance on the primary outcome, which was an objective measure of secondary attention. Click here to read the full article.

True to the source. True to the science. High quality translations for life science companies at a world class standard.

VeraSci Global Language Solutions, the translation and cultural adaptation arm of VeraSci, an innovative scientific services and technology company, has been awarded the ISO 17100:2015 certification.

This certification recognizes that VeraSci’s language services meet the International Organization for Standardization’s translation service provider requirements and have the resources and processes in place to deliver quality translations and meet client needs.

VeraSci Global Language Solutions pursued the ISO 17100:2015 certification to give their clients additional assurance that they will always receive world class translation and cultural adaptation services from VeraSci. The ISO 17100 Translation Services Management System is an internationally recognised standard which covers the essential processes for providing a translation service and ensuring good customer service.

According to Caren Gadigian, President of VeraSci:

“Pursuing the ISO 17100:2015 certification for VeraSci Global Language Solutions is both a strategic investment in our translation and cultural adaptation services and a continued commitment to being a premier provider of global clinical trial services and technologies.”

Colin Watkins, Lead Assessor comments:

“VeraSci were well aware of the requirements of the standard.  The policies and procedures, qualifications and skill levels of all personnel involved and availability of technological resources were already established.  As a result, the certification process was conducted in a relatively short period of time and all those who took part can be congratulated and thanked for their commitment and cooperation.”

VeraSci is the only language solutions provider to have linguists, subject matter experts, scientists, clinicians, regulators, and software developers in-house. They offer translation, localization, interpretation, and training in over 150 languages and have worked on study-related manuals, medication labels and eClinical software translations.

VeraSci’s Vice President of Global Language Solutions, Susan Lloyd says:

“We are proud to be an ISO certified translation service provider. VeraSci Global Language Solutions treats every project with care and attention to deliver what we’ve promised on-time every time.”

Testing Industry-Grade Wearable Devices for Real-Time Functional Assessment.

VeraSci’s Innovation Lab led by Dr. Alexandra Atkins has begun evaluating the ease of use, sensitivity, and reliability of two industry-grade wearable devices for the real-time capture of gait and actigraphy measures. VeraSci, a global clinical technology, research, and development services company, is making significant strides toward the inclusion of validated wearable technologies for continuous passive data collection in clinical trials for those at risk for Alzheimer’s Disease (AD) and related disorders.

If appropriately implemented, measurements from certified wearable technologies have the potential to revolutionize the future of AD prevention trials by facilitating the development of siteless clinical trial designs. The project will also assess the relationship between wearable device endpoints and standard performance-based measures of cognition and function. The study enrolled the first of 100 older adults with and without subjective cognitive decline in late October.

Devices under investigation include a wireless insole worn in standard footwear that allows for continuous assessment of gait, walking and balance, and a wrist-worn device that offers continuous measurement of heart rate, motor activity, skin temperature, Galvanic Skin Response, and sleep. The devices were selected based on their potential to produce reliable endpoints that may ultimately pass the high bar set for use in regulated clinical trials. Primary considerations included measurement accuracy, data security, and potential for compliance with HIPAA and FDA-Part 11 regulations.

Dr. Luca Pani, VeraSci VP for Regulatory Strategy and Market Access Innovation, and former Director General of the Italian Medicines Agency commented, “The potential for greater integration of wearables in CNS trials to collect high quality real world evidence (RWE) before, during and after product approval is enormous. To be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process required by other currently accepted tools.”

Through their Innovation Lab, VeraSci continually seeks to improve the tools and methods of measurement in clinical trials in multiple therapeutic areas. Prior work includes the collection of robust normative data for 650 cognitively healthy individuals on the tablet-based Brief Assessment of Cognition (BAC) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a performance-based functional assessment that was recently accepted into the FDA qualification program for cognitive impairment in schizophrenia.