Total Consent Management
Upgrade to a complete consent management solution for better participant access and experience.
Expand Global Access to Trials
Accessible on any web-enabled device (BYOD or provisioned), our scalable solution can inform and consent participants anywhere in the world. Flexible enough for any country or site, you can easily collect compliant signatures (digital or wet-ink), on-site or remote with integrated TeleVisit.
Improve Participant Retention
Stay connected with your patients and their data. Real-time notifications help ensure compliance while patient and caregiver-friendly ePROs make it easy for sponsors to track toxicity and tolerability in real time.
Minimize Compliance Errors
Gain complete visibility and oversight into your trial with real-time monitoring of all consent activities within a single dashboard and ensure inspection-ready audit trails with fully integrated template management and version control.
Introducing Total Consent
- Self-service authoring tool to easily create engaging consent templates
- Biosample attribution to confirm storage permissions for consent objects
- Permission-based workflows by roles and responsibilities for secure control
- Designed to comply with all global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR
With the eConsent market expected to continue its ascent over the next ten years, it’s apparent to those who have used it that the “e” in eConsent stands for much more than electronic. Analysis and real-world examples show that it can be efficient, educational, and empathetic, leading to better participant education, reduced participant dropout, lower administrative burden for sites, reduced audit findings, and more.
Frequently asked questions
eConsent is an electronic way of consenting trial participants that can be done in-clinic or remotely using tablets, phones, or computers. Transcelerate defines eConsent as including multimedia which can be used to develop an interactive and engaging informed consent experience while offering flexibility for diverse learning styles (e.g., auditory, visual).
While Total Consent is an eConsent tool at heart, it features additional functionality, such as wet-ink signature support, that enables it to be deployed worldwide, in any country conducting clinical research. In addition, capabilities like TeleVisit are built into Medable’s Total Consent and don’t require additional tools or login credentials. To learn more visit our Total Consent Management page.
Total Consent can be used both in the clinic, at home, and anywhere where a trial participant has an internet connection across 60 different locales. Total Consent was designed to comply with all global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR. Medable’s Total Consent currently supports 115+ languages in over 60 countries.
Yes. Total Consent can scale to trials of all sizes, whether you need to deploy eConsent on one study or multiple studies. Our solution also provides more efficiency the more you use it by creating standardized delivery methods for your organization.
The latest from Medable
Efficient & empathetic: New Duke research shows the real power of eConsent
With the eConsent market expected to continue its ascent over the next ten years, it’s apparent to those who have used it that the “e” in eConsent stands for much more than electronic.
Analysis and real-world examples show that it can be efficient, educational, and empathetic, leading to better participant education, reduced participant dropout, lower administrative burden for sites, reduced audit findings, and more.
Complete the form below to grab your copy of our whitepaper and see what Duke had to say.
Evolving Total Consent: Introducing digitally-enabled biosample consent storage
Within biosample storage, a “nightmare scenario” exists that Medable and our clients discuss regularly.
Some years ago, a sponsor with tens of thousands of biosample specimens identified that they had lost the ability to link their biobank samples' documented consent for storage (and further research). The consent for these samples was taken on paper, but a system to collate and file the consent data attributed to each specimen was not implemented. When the organization couldn’t find the paper consent, they were forced to dispose of thousands of biospecimens, losing the ability to conduct valuable research and potentially millions of dollars of lost IP.
How partnership ensured a successful first digital trial
For the last twenty years, clinical trials have been steadily digitizing.
As the EDC and eTMF systems of the early 2000s gave way to the eCOA and eConsent tools of the 2010s, site, and participant experiences throughout clinical research were improved.
Since our inception in 2015, Medable has conducted over 300+ digital and decentralized trials using eCOA, eConsent, telehealth, and more. However, just as a bell curve shows, adoption rates for new technologies can wildly vary across our industry. While some organizations quickly implement new technologies, others take a more cautious approach.