- Efficiency: E-consent replaces paper-based processes with digital platforms to streamline clinical trial enrollment.
- Accessibility: Remote consent features allow participants to join trials regardless of geographical location.
- Comprehension: Multimedia and interactive elements help participants make better-informed decisions.
- Top Providers: Leading companies include Sano Genetics, Medidata, Florence Healthcare, and Veeva.
It is worth distinguishing e-consent from related approaches. Remote consent, sometimes called teleconsent, refers to any consent process where the study team and participant are not in the same location, and it can use either paper or electronic forms. E-consent specifically involves an electronic system in place of the paper consent form. Not all e-consent platforms can document legally effective signatures, and for FDA-regulated research that poses more than minimal risk, systems must meet 21 CFR Part 11 compliance requirements.
Despite these advantages, deploying e-consent in practice is not straightforward. Institutional concerns around data privacy, third-party access to participant communications, and version control across sites frequently contribute to approval delays. For sponsors and CROs running multi-site or international programs, selecting the right e-consent partner requires evaluating not just usability but also regulatory alignment, integration capability, and long-term compliance support.
Below, we highlight five companies that provide solutions for e-consent and prescreening, each addressing different aspects of these challenges.
Top e-consent solution providers
- Sano Genetics: provides e-consent as part of a unified precision patient platform that connects prescreening, genetic testing, participant engagement, and study analytics within a single compliant system. Consent forms are configurable per study and geography, and the platform supports integration into sponsor, CRO, or site workflows. Sano is ISO 27001 certified and compliant with both HIPAA and GDPR, with security practices that include regular audits and penetration testing.
- Medidata: provides e-consent services in a secure and streamlined way, enabling patients to make informed decisions about participating in clinical trials through an intuitive interface while also providing researchers with real-time tracking.
- Florence Healthcare: offers comprehensive e-consent services to digitize the consent process, enabling remote collaboration, electronic signatures, and centralised document management through a cloud-based platform.
- Medrio: e-consent services provide a secure and user-friendly platform for researchers to obtain informed consent in clinical trials; features include digital signatures, customizable consent templates, and audit trails.
- Clinical Ink: offers eSource technology, which helps improve patient comprehension, simplify workloads for sites and study teams, and improve data quality to support decision making and regulatory compliance.
Selecting an e-consent platform is not purely a technology decision. Clinical teams need to evaluate several dimensions before committing to a solution:
- Regulatory alignment. For FDA-regulated research posing more than minimal risk, the system must be 21 CFR Part 11 compliant. Not all platforms meet this standard.
- Signature validity. Not all e-consent systems can document legally effective signatures. This distinction matters for studies that require formal documentation of consent.
- Institutional acceptance. Privacy and security requirements vary by institution, and concerns around third-party communication with participants can delay approval if not addressed early.
- Version control. In multi-site studies, sites often customize consent forms, creating version control challenges that are difficult and resource-intensive to manage without a centralized system.
- Workflow integration. E-consent is most effective when it connects to the broader participant journey, including prescreening, eligibility confirmation, and ongoing engagement, rather than operating as an isolated step.
The five companies listed above each approach these challenges differently. The right choice depends on the study design, regulatory context, and how consent fits within the broader enrollment and engagement workflow.
To explore how Sano Genetics integrates e-consent into precision medicine recruitment and engagement workflows, learn more about our prescreening and digital consent capabilities or get in touch.