Best-in-class eConsent software: improve trial retention rates, protocol adherence.

When clinical trial participants better understand trial protocols and associated risks and benefits, they are able to have a meaningful consent conversation where their questions and concerns are addressed. This digital clinical trial engagement favorably impacts participant conversion, protocol adherence, and retention rates. 5thPort’s eConsent software is digital, simplifying clinical trials consent related audit and regulatory compliance. It also helps to drive DE&I (Diversity, Equity and Inclusion) in decentralized clinical trials. 

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5thPort’s eConsent software delivers more than just better health outcomes…

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Engage
Leverage a smart informed eConsent process, combined with multimedia patient education and teach-back to create customized pre- and post-consultation educational teaching suites.
Efficient, Integrated Architecture
Eliminate the need to go from system to system, paper to paper. With 5thPort, your patient education and eConsent activities are streamlined into one platform that supports FHIR-based integrations to EHR, EMR, eReg and CTMS platforms.
Device-Agnostic
Most patients review education and eConsent resources on their smart phones or a personal computer. Patients like the flexibility to consume the material at their pace from any device. We also cater to BYOD.
Multilingual
Technology needs to be able to address patients in their spoken language. 5thPort’s intuitive menus allow patients to effortlessly switch between languages, reducing socio-economic and cultural barriers.
Consistent
Reduce clinician and nurse burnout by delivering standardized patient engagement plans and eConsent documents digitally, at scale. Automated reminders greatly alleviate the need for manual intervention.
Compliant and Secure
5thPort has been externally validated and reviewed to be compliant with HIPAA, 21 CFR Part 11, EU Annex 11, GDPR, ADA, ICH-GCP and more. Full audit trail and multi-factor authentication ensure security.
Versioning and ICF Management
Creating new ICFs is efficient, as they can be quickly duplicated from existing forms. The system supports streamlined version control where patients can easily re-consent when protocols are amended.
User Management
We support flexible roles to enhance the consent workflow. These include Patients, Caregivers/Guardians, Study Administrators, Site Administrators, Investigators, Monitors, and Read-Only Users.

Our eConsent software brings you real-time analytical prowess you can trust.

Allow our analytics to guide your assessment of patient education and eConsent effectiveness and identify opportunities to improve your patient’s comprehension of medical information presented to them.

With 5thPort’s eConsent software, you can analyze response trends across engagement channels (email and SMS), understand the effectiveness of your videos, questionnaires, surveys, and teach-back. Armed with this data, you have the opportunity to adjust your workflows to gauge and improve clinical trial participant satisfaction in near real-time. 

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Analytics Dashboard - 5thPort

In an era of increasing compliance requirements, 5thPort’s eConsent software reduces the risk of regulatory penalties.

The convenient One Touch Compliance (OTC) Report digitally documents every action taken by clinical trial participants and staff during the patient education and eConsenting process – including time and date stamps, as well as, the staff who completed said action. 5thPort’s eConsent software also ensures seamless version control and efficient re-consenting, so patients always receive the most up-to-date information while maintaining full regulatory compliance.

What does that mean for you?

1. Digital documentation at your fingertips
2. No stress compliance with internal or external consent audit requests
3. Solid risk mitigation

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