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eConsent for Clinical Trials

Obtain informed consent from patients with Datatrak’s eConsent software to gather data directly from the patient remotely through any device. Whether your trial is hybrid or decentralized, simplify the capture of digital data from patients and sites, while enhancing the quality of data with Datatrak. Datatrak’s eConsent has many additional features than the industry standard — except for what it will cost, which is below the industry standard and far less prohibitive for study sponsors and CROs.

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Increase Patient Engagement & Retention

Harness the power of informative videos, questions to measure comprehension, diagrams, images and study retention.

Flexible Design Capabilities

Build forms the way your team sees fit and make set up a breeze with pre-built libraries of standard eCOA forms.

Ensure Accuracy

Reduce confusion and error by enforcing workflows through edit checks based on the protocol.

Natively Integrated

Natively Integrated with EDC, RTSM, eTMF, and More

Datatrak’s eConsent has many additional features than the industry standard — except for what it will cost, which is below the industry standard and far less prohibitive for study sponsors and CROs. Natively integrated with Datatrak EDC, RTSM, eTMF, and other functions for a seamless, all-in-one experience.

See How It Works

Gather data directly from patients remotely through any device
Supports hybrid and decentralized clinical trials
Simplifies digital data capture from patients and sites
Improves trial diversity by meeting DEI criteria with Datatrak DCT
Enhances data quality throughout the trial lifecycle

Integrated Solutions

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Electronic Data Capture (EDC)

A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.

Explore EDC Software →

Clinical Trial Management (CTMS)

Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.

Explore our CTMS →

Electronic Trial Master File (eTMF)

Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.

Explore ETMF Software →

eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

Explore EConsent Software →

Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with a cloud-based pharmacovigilance software platform built for compliance.

Explore PMS Software →

EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

Explore EHR Systems →

Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

Explore trial design services →

Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

Explore Data Management →

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user friendly, and site staff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

Frequently Asked Questions

What is eConsent in clinical trials?

eConsent is the digital method for obtaining informed consent from patients participating in a clinical trial. Datatrak’s eConsent software gathers consent directly from the patient remotely through any device, and whether your trial is hybrid or decentralized, it simplifies the capture of digital data from patients and sites while enhancing the quality of data throughout the trial lifecycle.

How does eConsent improve patient engagement and retention?

Our eConsent harnesses the power of informative videos, questions to measure comprehension, diagrams, and images so patients understand what participation involves before they sign. Edit checks based on the protocol enforce workflows and reduce confusion or error, which helps keep patients engaged from the first visit through study close-out.

What makes Datatrak’s eConsent different from other platforms?

Datatrak’s eConsent has many additional features than the industry standard, except for what it will cost, which is below the industry standard and far less prohibitive for study sponsors and CROs. It is natively integrated with Datatrak EDC, RTSM, eTMF, and other functions for a seamless, all-in-one experience across the full trial lifecycle.