Pennsylvania-based Signant Health (formerly CRF Health and Bracket), which provides a suite of electronic clinical outcome assessment (eCOA), eConsent and patient engagement solutions, announced that it will provide electronic informed consent for a significant neuroscience study by the Shanghai Mental Health Centre (SMHC). SMHC is an affiliate of Shanghai Jiao Tong University, a leading organisation on mental health prevention planning.
The investigator-led Schizophrenia trial, which will enroll hundreds of patients at multiple sites, will be the first study to implement Signant’s TrialConsent solution in China.
WHAT’S IT ABOUT
Using multimedia videos, knowledge quizzes, self-paced content review and other patient-centric eConsent capabilities, TrialConsent will help people considering enrolling in the trial – and their families – understand expectations, risks and benefits in order to make an educated participation decision. This means patients will be more engaged with sites from the beginning, which supports patient retention throughout the study. At the same time, SMHC will benefit from a collaborative consent design process with IRBs and other stakeholders, real-time review of incoming patient consent and compliance data, and automated document management to prevent most consent-related audit findings.
THE LARGER TREND
Last May, then CRF Health’s (CRF Health was rebranded as Signant Health in June this year) eCOA tool was approved for an insomnia trial being held by an unnamed European pharmaceutical company. CRF Health also announced in April 2018 that its TrialMax Touch and TrialMax Slate products will be implemented in a phase 3 clinical trial conducted by an unnamed Japanese pharmaceutical company. The study will enroll 800 screened and 320 randomised subjects across 40 U.S. trial sites.
In 2016, CRF Health acquired pioneering digital health company Entra Health for an undisclosed amount. The acquisition expanded CRF’s offerings into the mobile and wireless medical device sector, helping to establish the global company’s network of solutions to collect, manage and analyse biometric and clinical trial data.
ON THE RECORD
“Signant Health, with global operations across thousands of sites, was selected for its pioneering patient facing clinical trial technologies, for understanding the unique needs of clinical trials in Asia-Pacific, and most notably proven scientific capabilities across the complex field of neuroscience,” said Dr. Shen, associate professor and vice director of medical psychology in the Mental Health Department at Shanghai Jiaotong University, and vice director of the Department of Psychology, SMHC, in a statement.
“SMHC was confident Signant could support the large-scale investigator led study involving several hundred subjects across numerous hospital sites, generating significant data. Robust data collection is critical and patient-centric digitisation of the eConsent process will deliver enormous benefit to all stakeholders in this important study,” Shen added.
Mike Nolte, CEO at Signant, said: “Clinical research in China, and the Asia-Pacific region, is evolving rapidly with valuable advancements that benefit the entire global community. Signant Health’s growing work in Asia supports accelerating demand from life science companies and academic partners in this region for the pioneering services we provide – our deep therapeutic area expertise, Scientific and Clinical Consulting, and Data Quality Analytics that leverage technology to transform the quality and impact of their research studies.
“We are honoured to partner with such a prestigious body as SMHC as they continue to achieve significant milestones and global reach with their outstanding clinical research programmes in such a critically important area.”