eConsent Software for Clinical Trials – A Modern Solution for On-site & Remote Studies

Create an effortless experience for your decentralized study participants with Castor’s all-in-one eConsent solution. Recruit, screen and enroll patients from the comfort of their home.

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Castor’s eConsent software platform is an all-in-one solution for clinical trials

Castor’s suite of modular eConsent solutions creates clinical trial efficiencies from recruitment and screening, all the way to direct data capture and analysis.  Each virtual element can be integrated into your traditional, hybrid, or fully decentralized trial as a standalone solution, or packaged together as an all-in-one eConsent platform.

 
eConsent Software Tablet

Recruit and enroll study participants with a streamlined onboarding experience

Increase patient access and diversity with remote enrollment. Recruit study sign-ups through a customized recruitment portal and pre-screen with questionnaires to help filter for qualified applicants. Once electronic informed consent is captured, patient data from enrolled participants can automatically be updated in Castor EDC, ready for the next step.


Improve eConsent completion with secure video visits

Host remote eConsent visits with video to engage study participants in the comfort of their home. No switching between applications – video calls, signatures, and questionnaires are all built-in to Castor’s clinical trial platform to reduce complexity and increase your patient’s experience.

eConsent Platform Process on Mobile Device

eConsent table

Easily track progress and gain real-time insights on the enrollment funnel

Study coordinators can see in real-time where patients are in their enrollment process and assist patients while meeting regulatory requirements.

17,824 patients in 15 weeks

Launching a DCT on Castor’s platform

World’s first study to use machine learning in diagnosis of COVID-19, supported by TAKEDA and Julius Clinical

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“Using Castor, we succeeded in recruiting over 17,824 patients enrolled in 15 weeks during a global pandemic, an achievement that could not have been accomplished without tools purpose-built with decentralized trials in mind.”

Marcel Van Willigen
Julius Clinical

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Key features

video Video visits for remote eConsent

No 3rd party plugin or download required. Ensure transparency and enhance study comprehension for study subjects with secure, encrypted video calling.

recruitment Automated digital patient recruitment

Study subjects can enroll themselves organically using a customizable patient portal landing page and/or study managers can manually send patients invites to enroll in a clinical trial.

versioning Versioning & ICF management

Multiple consent forms are available for a single site and/or across multiple sites. ICF statuses and versioning ensures sites are always using the correct version. New ICFs can be created quickly by duplicating existing ones. Patients re-consent for amended protocols.

compliance Compliance

21 CFR Part 11 electronic signature compliant and industry leading encryption, protects patient privacy, and ensures tamper-proof eConsent. Full audit trail and multi-factor authentication ensure ease of use and security.

integrate clinical data Integrated platform and open architecture

Native integration with Castor product suite (EDC and ePRO app) to allow uninterrupted data capture flow in a single ecosystem. Flexibility to integrate with other eClinical technology vendors through RESTful API.

user management User management

Flexible roles that help the consent workflow and multicenter study responsibilities: Patients, Care-givers/Guardians, Study Admin, Site Admin, Investigator, Monitor and Read-only users.

FAQs

Frequently asked questions about eConsent software

Answers to the most common questions about eConsent software, electronic informed consent regulations and how Castor supports your study from recruitment to enrollment.

What is eConsent?
eConsent (electronic informed consent) is a digital process for obtaining, documenting and managing informed consent from clinical trial participants. eConsent software replaces paper-based consent forms with secure, validated digital workflows that can be completed on-site or remotely. eConsent improves patient understanding, reduces screen failures and creates a complete, tamper-proof audit trail for regulatory submissions.
What is the difference between eConsent and traditional informed consent?
Traditional informed consent relies on paper forms and in-person visits to obtain patient signatures. eConsent replaces this with digital workflows that support video calls, electronic signatures and real-time status tracking. eConsent can be completed remotely or on-site, reduces administrative burden for sites, and provides a better patient experience with multimedia content to aid comprehension.
What regulations govern eConsent in clinical trials?
eConsent in clinical trials is governed by multiple regulatory frameworks including 21 CFR Part 11 (FDA, US) for electronic records and signatures, ICH E6(R3) Good Clinical Practice guidelines, and EU Regulation 536/2014 for clinical trials in Europe. Castor’s eConsent software is 21 CFR Part 11 compliant with industry-leading encryption, multi-factor authentication and a full audit trail.
How does eConsent improve clinical trial recruitment?
eConsent software improves recruitment by removing geographic barriers to participation. Patients can complete consent forms remotely from home, which increases access and diversity in trial populations. Integrated pre-screening questionnaires help filter eligible participants earlier, reducing screen failures. Castor’s eConsent platform also includes a customizable patient recruitment portal that automates enrollment workflows from first contact to EDC data entry.
Can eConsent handle hybrid enrollment models?
Yes. Castor’s eConsent software supports on-site, remote and hybrid enrollment models within the same platform. For hybrid trials, sites can conduct consent visits in-person or via secure video call, with the same compliance standards applied across both. The platform supports multiple sites, multiple languages and parallel consent form versions, making it suitable for global multi-site studies of any design.
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This project is supported by the Kansen voor West II program run by Noord-Holland, Zuid-Holland, Utrecht, Flevoland, Amsterdam, Den Haag, Rotterdam and Utrecht. This program is funded by the Europees Fonds voor Regionale Ontwikkeling fund.