DATATRAK Standalone eConsent Accelerates Clinical Trials

Rhea-AI Summary

DATATRAK (OTC:DTRK) launched a standalone eConsent solution that deploys in under four weeks, integrates with any EDC, and is available as a lightweight, cost‑effective module or as part of the DATATRAK Powered by Fountayn platform.

The product supports remote and site‑based enrollment, protocol amendments and re‑consent tracking, multi‑device patient access, QR/email invites, and integration with RTSM, CTMS, and eTMF to streamline startup timelines and lower technology costs.

eConsent solution deploys in under four weeks, integrates with any EDC, and delivers affordable, patient‑centric digital consent

AUSTIN, TX / ACCESS Newswire / February 26, 2026 / DATATRAK International, Inc.'s (OTC:DTRK) DATATRAK Powered by Fountayn unified eClinical, eSource, and decentralized clinical trial (DCT) platform, announces the release of its standalone eConsent solution designed to help sponsors, CROs, and sites modernize informed consent while reducing startup timelines and technology costs. The new eConsent offering can be deployed in under four weeks and is available as a lightweight, cost‑effective module or as a fully integrated component of the DATATRAK Powered by Fountayn EDC and DCT ecosystem.

Unlike many eConsent tools that are bundled only within large, expensive ePRO or DCT packages, DATATRAK's standalone eConsent delivers flexible pricing so study teams can implement digital informed consent without paying for an entire ePRO system they do not need. Reasonable, study‑level pricing makes eConsent accessible for a broader range of trials and budgets, including early‑phase, single‑site, and investigator‑initiated studies.

"Study teams want the benefits of modern eConsent-faster startup, better participant understanding, and cleaner documentation-without lengthy implementations or bloated platform costs," said Alex Tabatabai, CEO, DATATRAK. "Our standalone eConsent is purpose‑built to launch quickly, fit into existing study infrastructure, and scale seamlessly when sponsors are ready to expand into DATATRAK EDC, ePRO, RTSM, CTMS, or full decentralized clinical trials."

Fast Startup, IND‑Ready Timelines

The DATATRAK eConsent solution is designed for implementation timelines of under four weeks, allowing study teams to go live in time for IND or ethics approval and first‑patient‑in milestones. Configuration is supported by reusable templates and best‑practice workflows that help streamline approvals and site activation.

Standalone eConsent with Enterprise‑Grade Integration

The eConsent module can be used as a standalone utility and integrated with third‑party infrastructure, including external EDC, RTSM, CTMS, and eTMF systems, or deployed as a native component of DATATRAK EDC. When used with DATATRAK EDC, consent data and enrollment status are seamlessly connected to subject records, randomization, and visit schedules, enabling true end‑to‑end digital trial execution on a single platform.

Key Capabilities Include:

1. Standalone eConsent that integrates with third‑party clinical trial systems or EDC
2. Seamless integration with the consent and enrollment workflow in EDC
3. Support for remote and decentralized clinical trials with patient access from any device
4. Designed for protocol amendments and regulatory workflows

DATATRAK's eConsent simplifies managing protocol amendments and re‑consent, a common pain point for sponsors and sites. Study teams can easily trigger and track re‑consent when protocol changes occur, ensuring every participant is on the correct version and that audit trails remain inspection‑ready.

The system also supports tracking and managing supporting documents such as witness statements, translations, and supplemental information, helping maintain complete, compliant records across sites and regions.

Flexible Patient Engagement and Enrollment Options

To support both site‑based and remote enrollment, the eConsent solution enables sites to invite participants using multiple methods: email links, QR codes patients can scan on their own device, or direct registration by the physician or site staff. Sites can also schedule consent visits prior to trial enrollment, helping ensure participants have adequate time to review materials, ask questions, and complete consent in a controlled, compliant workflow.

When combined with DATATRAK's EDC, ePRO, and eSource capabilities, sponsors can extend the same patient‑centric digital experience beyond consent to ongoing data collection and engagement throughout the study.

About DATATRAK

DATATRAK Powered by Fountayn is transforming healthcare and life sciences through technological innovations by providing a unified, cloud based eClinical and decentralized clinical trial platform that brings together EDC, eSource, ePRO/eCOA, eConsent, RTSM, RBM, Adjudication, Imaging, Safety, Global Oversight and Enterprise Workflow Management, CTMS, eTMF, and DCT tools in a single, configurable environment. With global access from any device and a single‑source data model, DATATRAK helps sponsors, CROs, and sites accelerate study timelines, improve data quality, and reduce operational burden across all phases of clinical research. DATATRAK complies with the highest Quality Assurance standards that are 21 CFR Part 11, GDPR, GCP, HIPAA, and CDISC compliant that are fully validated by our experienced team of software quality engineers. DATATRAK's cloud-based platform is trusted in 83 countries, 6 continents, for over 10,000 clinical trials. DATATRAK is based in Austin, Texas and has team members and data hosting infrastructure in its key service regions of the United States, Europe, and Japan. For more information, visit www.fountayn.com or www.datatrak.com.

Contact: sales@fountayn.com

SOURCE: Datatrak International

View the original press release on ACCESS Newswire

FAQ

How fast can DATATRAK (DTRK) deploy the new standalone eConsent for a clinical trial?

DATATRAK says the standalone eConsent can be deployed in under four weeks for study startup. According to DATATRAK, reusable templates and best‑practice workflows help accelerate IND or ethics approval and first‑patient‑in timelines.

Can DATATRAK eConsent (DTRK) integrate with our existing EDC or third‑party systems?

Yes — the eConsent is designed to integrate with third‑party EDC, RTSM, CTMS, and eTMF systems. According to DATATRAK, it also functions natively with DATATRAK EDC for seamless consent, enrollment, and visit schedule linkage.

What patient access and enrollment methods does DATATRAK eConsent (DTRK) support?

The system supports remote and site‑based enrollment via email links, QR codes, or direct site registration by staff. According to DATATRAK, participants can access consent materials from any device and schedule consent visits before enrollment.

How does DATATRAK eConsent (DTRK) handle protocol amendments and re‑consent?

DATATRAK provides tools to trigger, track, and document re‑consent when protocol changes occur, keeping records inspection‑ready. According to DATATRAK, audit trails, versioning, and supporting documents like translations are maintained across sites.

Is DATATRAK's standalone eConsent cost‑effective for small or early‑phase studies (DTRK)?

DATATRAK positions the standalone eConsent with study‑level, flexible pricing suited to early‑phase and single‑site trials. According to DATATRAK, pricing avoids requiring full ePRO packages, lowering technology barriers for smaller studies.