WCG today announced the acquisition of VeraSci, a global provider of specialty scientific expertise and eClinical software to support the design and execution of clinical trials focused on central nervous system (CNS) disorders. The addition of VeraSci, based in Durham, North Carolina, deepens WCG’s scientific and patient engagement capabilities, and complements its CNS offerings, including those available via the Company’s MedAvante, ProPhase and Analgesic Solutions businesses. With this expansion, WCG is addressing the growing demand for proven scientific and technology solutions to power remote data capture, hybrid virtual studies and fully decentralized clinical trials in key CNS therapeutic areas.

“WCG’s acquisition of VeraSci represents a natural next step and an exciting growth opportunity,” said Donald A. Deieso, Ph.D., Executive Chairman and CEO of WCG. “On behalf of WCG, I’m proud to welcome VeraSci, an organization that shares our dedication to improving the clinical trial experience for patients and sites, commitment to scientific rigor and passion for bringing novel technologies into clinical trial processes. This is a marriage of two premier global teams with a common vision.”

VeraSci provides clients around the world with innovative solutions that improve data quality in clinical trials, including endpoint and assessment services, rater training and certification, language and translation support, and eCOA and ePRO technologies. With its Pathway technology platform, which can be easily configured to meet the needs of any study across the globe, VeraSci enables the collection of high-quality data that can be used to assess symptoms, cognition and functional capacity in a wide range of therapeutic indications.

“Since our inception, we have invested in expanding VeraSci’s expertise and capabilities to include a variety of clinical and regulatory endpoints covering a range of diseases and disorders. We have also pioneered technological advances that are changing the way subjective endpoint assessments are conducted in clinical research,” said Rich Keefe, Ph.D., CEO and Co-Founder of VeraSci. “Now, as part of WCG, we are positioned to be the go-to research partner around the globe. We can scale and further strengthen our offerings, including our industry-leading CNS services and solutions.”

Dr. Keefe added: “For all of us at VeraSci, it’s truly an honor to join WCG and a thrill to work alongside colleagues who are just as committed to enabling well-designed, science-focused processes and technologies to drive more effective, efficient and patient-centric clinical trials.”

Caren Gadigian, President and Co-founder of VeraSci remarked, “Dr. Keefe and I have worked tirelessly for 16 years to develop VeraSci to where it is now. We look forward to maintaining our commitment to science and to the benefit of patients in need through our new partner.”

As an industry leader in neurocognitive measurement and with its deep therapeutic and technical expertise in psychiatric disorders, VeraSci also enriches WCG’s capabilities designed to solve the overarching challenges of CNS clinical study planning and execution. VeraSci’s experience encompasses all phases of development, from single-site, phase I studies to global phase III trials, with hundreds of raters and thousands of patients.

“Whether we’re discussing stroke or migraine, epilepsy or multiple sclerosis, or Alzheimer’s or Parkinson’s disease, on average, developing drugs to treat CNS disorders takes 20% longer than drugs for other indications and 38% longer to secure regulatory approvals. These challenges are largely due to limitations in understanding the underlying disease, as well as in identifying and measuring appropriate clinical endpoints,” said Lindsay McNair, MD, Chief Medical Officer of WCG. “The VeraSci team is composed of highly-respected scientists, industry thought leaders and operational experts, including Dr. Keefe and Dr. Luca Pani, VeraSci’s Vice President of Regulatory Strategy and Market Access Innovation, who is also the former Director General of the Italian Medicines Agency. Their combined experience and expertise in clinical psychology, neuroscience, clinical pharmacology and regulatory science, with particular emphasis on technology-enabled, remote endpoint assessments, will be extremely valuable to clients and, more broadly, our industry, as we work together to enable advances in CNS treatments, which improvements in the clinical trial process have tremendous potential to accelerate.”

Emmanuel Olart, WCG’s Chief Applications Officer, noted: “Since our founding in 2012, WCG has been preparing for what we have seen coming as the future of clinical research, working hand-in-hand with sponsors, CROs and sites, and providing them with innovative technologies and solutions to improve clinical trial efficiency and effectiveness. Acquiring VeraSci is part of that ongoing effort, bringing clinical trials closer to patients, reducing the burden of participating and making the experience better for them via solutions that enable remote data capture, hybrid virtual studies and fully decentralized clinical trials.”

Moving forward, VeraSci will be known as WCG VeraSci. The organization will retain its leadership structure and continue to operate from its headquarters in North Carolina.

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 WCG
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two segments, Ethical Review and Clinical Trials Solutions (CTS), WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. For more information, please visit www.wcgirb.com, www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.

The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a new Innovative Medicines Initiative (IMI) funded project to find an ethical and GDPR compliant framework for returning clinical trial data to study participants, a key step in reconciling the promise of avoiding useless repetitions of studies with privacy rights of individuals. VeraSci will serve on the Medical and Technical Expert Decision Committee for the project. Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci will serve as the Project Coordinator in his role as Professor Pharmacology and Clinical Pharmacology at the University of Modena and Reggio Emilia in Italy.

About FACILITATE

There has been growing concern that the EU General Data Protection Regulation (GDPR) safeguards will make Europe non-competitive in the innovative drug development space. Here are a few ways GDPR may complicate clinical trials in drug development:

  • The principle of data minimization may preclude machine learning
  • Privacy by default and design may preclude predictive analytics
  • Clinical data reutilization requires access to enough “detailed information,” which GDPR restrictions could make difficult or impossible

In addition to creating an ethical and GDPR compliant framework to return clinical trial data to study participants, FACILITATE seeks to:

  • Find legally robust and ethically forward-looking ways to allow patients’ data to be accessed, used, and re-used
  • Generate a partnership where patients are at the center of data governance
  • Show how a patient-centered data-driven approach can make the entire drug development and approval process better
  • Avoid storing clinical data in siloed systems where there is no possibility to use them beyond their original (and often single-sided) purpose

 

Like clinical trials in adult populations, pediatric clinical trials increasingly incorporate electronic patient-reported outcome (ePRO) systems to gather data directly from patients. One challenge unique to pediatric trials is that many trials also seek to gather information from one or more caregivers, known as informants. The chosen informant is often a parent, but depending on the individual child’s family situation, multiple people may fulfill this role—mothers and fathers in separate households, grandparents, or stepparents. In some instances, a patient and their parent may share a device. In others, the patient and each parent may have separate devices.

These varied situations mean that pediatric trials utilizing informants need maximum flexibility in an ePRO solution—all while maintaining the same level of data security, traceability, and regulatory compliance (FDA 21CFR Part 11 and GDPR). The ePRO solution should allow multiple informants to enter data across multiple devices and device types, each with a unique username and password. Ideally, informants should be able to access the system on mobile devices (Android and iOS) and online through a desktop computer.

Sponsors considering ePRO in pediatric trials may also want to consider a hybrid approach that allows for both bring-your-own-device (BYOD) and provisioned devices. Many parents and caregivers will prefer the convenience of accessing diaries and questionnaires from their phones. Some caregivers, including grandparents, may not have access to a smartphone and are more likely to participate if given a provisioned device. Additionally, provisioned devices can also be used to capture data from pediatric patients when they are not with a parent or caregiver whose device they usually use. If provisioned devices will not be used, it is vital to ensure that patients can access the system across multiple devices. This is particularly true in shared custody situations where routinely getting access to the same device may be prohibitive to participating in a trial.

Learn how Pathway can provide the features you need to support your next pediatric clinical trial.

View Pathway ePRO Demo

Adolescent oncology patients can be vulnerable to a great deal of emotional and behavioral challenges. But which young people are most susceptible is very difficult to predict. An article recently published in Frontiers in Oncology discusses how digital phenotyping and dynamic monitoring present an opportunity to understand and predict which patients are at the most significant risk.

The article, “Digital phenotyping and dynamic monitoring of adolescents treated for cancer to guide intervention: embracing a new era” was co-authored by Dr. Luca Pani, VP of Regulatory Strategy and Market Access Innovation at VeraSci.Adolescence is an important period for physical, social, and emotional development. It is also the time when many mental illnesses first emerge. For adolescents with cancer, general vulnerability to mental illness is compounded by physical and psychological symptoms associated with treatment and interruptions in relationships with their peers. While some adolescents can develop great emotional and mental resilience during the course of their cancer treatment, it is often difficult to distinguish the resilient from the vulnerable, which can prevent timely intervention. Digital phenotyping captures ongoing objective measurements in patients’ daily lives, provides a continuous stream of information, and uses real-time algorithms to detect any pattern changes that may be cause for alarm.

Read the full article to learn more.

The journal Clinical Drug Investigation recently published the article “New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing” which was co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. As the number of advanced therapy medicinal products (ATMPs), such as gene therapies, increases, it becomes clear that the existing health technology assessment (HTA) process is not sufficient anymore to give the right value to such treatments. The objectives of this article are to discuss why the current HTA process is inadequate for evaluating these new therapies, how evidence should be continuously generated and presented to regulators and payers to support their use, and to propose new approaches to pricing models. Without new approaches or adaptation of existing frameworks, certain ATMPs may not reach patients in some or all countries or be at risk of withdrawal from the market.

Read more

Today, Boehringer Ingelheim announced that they are partnering with VeraSci on an innovative phase III program in cognitive impairment associated with schizophrenia (CIAS) for the investigational treatment BI 425809. The FDA has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of CIAS.

The program will be using VeraSci’s Pathway eCOA platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic and interactive virtual environment. The VRFCAT, which is sensitive to functional capacity deficits, has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program. The trials will also utilize speech biomarker technology from Aural Analytics, which will provide a richer picture of trial participants’ language function alongside more traditional clinical outcome measures.

“VeraSci is excited to take part in this landmark innovative trial in CIAS,” says VeraSci CEO Dr. Rich Keefe. “Innovative solutions are imperative to making meaningful progress in this difficult illness. We are hopeful that this research will be an important step forward for the field.”

Read the full announcement