Medable, the industry-leading technology platform for patient-centered clinical trials, today announced the availability of its Total Consent offering, a fully enabled SaaS electronic consent management solution compatible with every clinical trial, in more than 120 locales around the globe. With this launch, Medable’s Total Consent offering is at the forefront of optimizing the informed consent process for potential trial participants by improving patient accessibility, knowledge, and experience, in line with the release of the proposed FDA rule, Protection of Human Subjects and Institutional Review Boards.
Clinical trials face enormous hurdles around patient recruitment and retention, including lengthy, convoluted consent processes that often leave patients confused or discouraged. These challenges are so widely recognized that the FDA proposed a new rule in September to enhance the consent process in order to invite broader participation and advance efforts to recruit diverse populations in clinical trials. Many trials run in multiple countries simultaneously and regulations around eConsent vary dramatically across the globe, adding to the complexity. These issues present a major challenge for life sciences companies trying to successfully improve the consenting process globally.
With Total Consent, Medable is transforming the consenting process – harmonizing it into one simple-to-use platform that enables trial sponsors and CROs to completely customize eConsent in more than 120 locales, in compliance with local regulatory requirements. This SaaS offering allows patients to consent onsite or remotely, with eSignature or wet ink signature. It includes print-to-sign templates, template management, and streamlined workflows – meaning countries that require wet-ink signatures can now benefit from Medable’s longstanding eConsent offering. Enhanced authoring tools also allow sponsors and CROs to include customized instructional videos and knowledge checks, further enhancing patient understanding and reducing site burden.
“Our efforts to boost trial recruitment, retention and diversity will fall flat if we do not solve the challenges around patient consent – for every trial, and in every geography. With Total Consent, Medable is proud to lead the charge, empowering trial sponsors and CROs around the globe to upgrade their entire consenting process and fully inform the patients they need for trial success,” said Andrew Mackinnon, Vice President and General Manager of Total Consent. “In addition to solving the previously intractable problem of global deployment, our SaaS solution also offers complete customization and unmatched deployment efficiency – resulting in speedier trials that fully reflect the populations they are meant to study.”
And, as with all its SaaS offerings, Medable provides Total Consent customers with in-depth training to enable faster deployment of eConsent across their trials – including a new rapid onboarding option. Total Consent also includes enhancements to its authoring tools, allowing customers to build eConsent platforms with their own branding and communications. This seamless user experience will help patients navigate complicated information and boost the likelihood that they will participate in the trial.
“One of the many lessons from COVID was the need to dramatically accelerate remote consent, both in terms of time and geography,” said Pamela Tenaerts, Chief Scientific Officer at Medable. “The industry, patient advocacy groups, and most recently the FDA all recognize that digital consent is essential for a patient-centric clinical research system that brings the best drugs to market as swiftly as possible. With Total Consent, we can finally pull in broader geographies of patients and put them at ease as they embark on their journeys toward better health.”