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.
- 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
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
You asked, we answered: How long to plan for your first eConsent implementation
Implementing digital informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be! One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.
What it really takes to adopt eConsent across large pharma
Learn about the benefits of adopting consent management technology and best practices around developing change management and training programs to help sponsors, CROs and sites get the most out of eConsent.
The importance of quality in the informed consent process
Join Aditum Bio's Shayanne Ali and Medable's Andrew Mackinnon, as they discuss the most common issues with the paper-based consent process, and what to look for in a complete consent management solution in order to reduce quality issues while improving oversight.