New eConsent moves from early adopter to general availability, unifying with IRT technology to help patients and practitioners more seamlessly navigate the demands of complex clinical trials
PHILADELPHIA (2022年5月19日) — Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system (CNS), and rare disease, today announced the broad availability of eConsent as part of its unified platform, providing a simplified solution that gives clinical trial teams more electronic control over the consent process. This offering will enable remote monitoring and the ability to track consents, screening, and randomization data in one place — increasing real-time visibility, ease of use, and efficiency, all while decreasing regulatory risk and alleviating the burden of re-consenting throughout the clinical trial journey.
Phase III trials — especially for life-saving therapies — can last years with numerous changes to treatment over the course of the trial. Currently, these trials have the highest protocol deviations. According to the Tufts Center for the Study of Drug Development January/2022年2月 Impact Report, protocols with three or more amendments add an average of three weeks to a treatment’s planned duration, resulting in an increased burden for study teams and a higher risk of mistakes. Suvoda has designed an easily adoptable solution that makes it simple to collect and store consent documents electronically — providing real-time visibility and remote monitoring that both minimizes potential problems with re-consenting that may appear down the road as well as inspection findings related to the overall informed consent process.
“Informed consent is a continuous process that must be repeated throughout a patient’s clinical trial journey, and no company is exempt from the possibility of lost data and time that re-consenting can bring,” said Jagath Wanninayke, CEO of Suvoda. “By listening to customers and patients throughout the early adopter phase, we have designed an eConsent solution that anticipates these challenges before they arise, while also simplifying the consent management with minimal or no changes to existing processes – both at the sponsor and the site.”
Despite the growing virtualization of clinical trials, some countries still do not allow e-signatures. However, Suvoda eConsent offers a wide range of flexibility to accommodate variances in regulations by country, consent types, consent methods, and device requirements — creating a clear consent process that keeps trials moving.
The Value of a Unified Platform
eConsent is one of three unified offerings on Suvoda’s platform that helps manage time-sensitive, mission-critical moments in life-sustaining trials for patients, sites, and sponsors. By uniting eConsent and IRT technology on a single platform, sponsors can share trial details with patients in an interactive manner, while increasing patient enrollment, compliance, and retention.
eConsent and IRT support remote monitoring by allowing clinical research associates to review data in reports through the portal instead of having to go on-site. Teams will be able to maintain real-time visibility of each patient’s consent status across study sites and track other key consent metrics alongside those tracked in IRT (e.g. consent, screening, randomization, dosing, visit schedule, re-consenting). This unified platform allows teams to ensure consented patients are assigned to the correct clinical trial protocol, and will help automate decisions by ensuring patients are re-consented before moving to their next step in the trial. This automated control, combined with remote monitoring, helps to safeguard quality and compliance.
In addition to eConsent and IRT, Suvoda offers eCOA, expected to be broadly available by the beginning of 2023. eCOA makes it easier for patients to report critical outcome data, making Suvoda’s seamless platform even stronger and better able to support the entire patient clinical trial journey.
Suvoda is a global clinical trial technology company that specializes in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest, Romania, and Tokyo, Japan. The company consistently boasts a Net Promoter Score (NPS) of close to 70, far exceeding the technology industry average of 50, and has been selected by trial sponsors and CROs to support more than 1000 trials across 65 countries. To learn more, visit suvoda.com. Follow Suvoda on Twitter and LinkedIn.