Total Consent allows users to provide the informed consent process for potential trial participants through a web-enabled device, which can be delivered to patients around the world.
According to Medable, Total Consent is able to navigate some of the hurdles facing patient recruitment and intention by simplifying the consent process for patients. With the tool also being navigated online, the challenge of receiving consent from participants in trials across multiple countries or regions is also reduced.
The company notes that the platform also allows patients to consent onsite, whilst also providing print-to-sign templates, template management, and streamlined workflows. Medable states that this means that countries requiring wet-ink signatures during the consent process can still use the eConsent offering.
Beyond this, the platform also provides authoring tools to allow sponsors and contract research organizations (CROs) to include customized instructional videos and knowledge checks, ensuring patient understanding during the process.
Andrew Mackinnon, VP and general manager of Total Consent at Medable, said, “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.”
Medable stated that the Total Consent solution is delivered to customers with training, including a new on-boarding option. The platform is also customizable to allow customers to build eConsent platforms with their own branding and communications.
Furthering its case for the utility of the Total Consent program, Medable cited the US Food and Drug Administration (FDA)’s proposed new rule over informed consent.
As part of the proposed changes, the FDA would require that key information most likely to help a potential participant understand the study be presented first before other information about the study.
According to the agency, the proposed changes, which are open for public comment through to November 28, 2022, would invite broader participation in clinical research, particularly, “to ensure that clinical trials reflect the diversity of patient populations and that these patient populations feel engaged by the clinical research community.”
Medable announced a partnership with CVS Health at the beginning of the year with the stated aim of broadening clinical trial access. According to the partners, this would be possible through the use of Medable technology in combination with CVS Health’s community reach and MinuteClinic resources.