DATATRAK Standalone eConsent Accelerates Clinical Trials
Published: 25 Mar 2026
Author: Precedence Research
DATATRAK International, Inc. announces the release of its standalone eConsent solution designed to help sponsors, CROs, and sites modernise informed consent while reducing start-up timelines and technology costs. This 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, 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.
According to Towards Healthcare, the Clinical Trials Management System (CTMS) Market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 17.77 billion in 2026 to approximately USD 32.94 billion by 2035, representing a compound annual growth rate (CAGR) of XX% from 2026 to 2035. The purpose‑built solution to launch quickly, fit into existing study infrastructure, and scale seamlessly when sponsors are ready to expand into DATATRAK EDC, ePRO, RTSM, CTMS, or a full decentralised clinical trial.
CEO, DATATRAK Alex Tabatabai, said Study teams want the benefits of modern eConsent-faster start-up, better participant understanding, and cleaner documentation-without lengthy implementations or bloated platform costs
Fast Start-up, IND-Ready Timelines
Study teams are allowed to go live in time for IND or ethics approval and first‑patient‑in milestones. The DATATRAK eConsent solution is designed for implementation timelines of under four weeks. Configuration is reusable templates and best-practice workflows that help streamline approvals and site activation.
Standalone eConsent with Enterprise-Grade Integration
Standalone utility and integrated with third-party infrastructure used in the eConsent module include external EDC, RTSM, CTMS, and eTMF systems, or deployed as a native component of DATATRAK EDC. When used with DATATRAK EDC, consent data and enrolment status are seamlessly connected to subject records, randomisation, and visit schedules, enabling true end‑to‑end digital trial execution on a single platform.
A recent report by Towards Healthcare highlights that the Clinical Trials Management System (CTMS) Market is designed for protocol amendments and regulatory workflows that support remote and decentralised clinical trials with patient access from any device. 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.