The landscape of clinical trials is rapidly evolving with the advent of digital transformation. One of the key innovations revolutionising the industry is electronic consent (econsent, e-Consent), a ground-breaking approach spearheaded by consent vendors to obtain participant consent before enrolment and throughout the trial to confirm their comprehension.
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e-Consent aims to streamline and simplify the consent process by harnessing digital technologies. It plays a vital role in clinical trials due to its significance across several key aspects including participant engagement and retention, efficient trial management, compliance and audit preparedness, as well as cost savings and resource optimisation.
The awareness on e-Consent significantly improved during the COVID-19 pandemic, which propelled the remote consenting clinical trials.
Explore the top econsent vendors and companies in clinical research
Clinical Trials Arena has listed some of the leading e-Consent companies based on its intel, insights, and decades of experience in the sector.
The list includes companies that offer various solutions and services, including but not limited to overall consent tracking management, clinical trial e-Consent systems, e-Consent tools, hybrid e-Consent platforms, electronic informed consent technologies, audit-ready consent documentation, and remote consent.
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The list also includes companies providing diverse features in their e-Consent platforms, such as wet-ink signature support, multimedia capabilities, televisit, customised electronic forms, reconsent, instant communication between participants and site, real-time tracking, and more.
The information contained within the download document is intended for clinical trials executives, consultants, patient-informed consent specialists, clinical trial project managers, product engineers, clinical monitoring managers, clinical research coordinators, recruiting coordinators, regulatory operations directors, safety scientists, and any other individual involved in e-Consent in the clinical trials industry.
The document contains detailed information on the providers and their product or service offerings, alongside contact details to aid your purchasing or hiring decision.
Role of e-Consent in clinical trials
With the increasing complexity of clinical trial protocols, the complexity of patient-informed consent forms and procedures also escalates. e-Consent proves to be a valuable tool for facilitating patient consent.
in trials with intricate designs, such as bucket and umbrella trials, which require multiple consents. It enables consent in challenging therapeutic areas and scenarios, such as oncology, paediatrics, and emergency medicine, where patients may require a legal representative to provide consent on their behalf. It supports sites with complex consent workflows and tracking during a trial.
The e-Consent platforms offer user-friendly interfaces and tools that streamline the consent process, ensuring that all necessary consents are obtained and documented correctly throughout the trial, ultimately reducing errors and enhancing compliance.
Solutions, such as Medidata’s Rave eConsent and Signant Health’s SmartSignals eConsent, offer a regulatory-compliant, patient-friendly, electronic consent system for completely transparent consent documentation for clinical trials that are ready for audits.
For full details (including contact details) on the leading companies within this space, download the free Buyer’s Guide below:
Frequently asked questions
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What is e-consent, and why is it important in clinical trials?
E-consent is the electronic method of obtaining informed consent from participants in clinical trials. It simplifies the consent process by allowing participants to review information, ask questions, and provide consent digitally. This method ensures that participants fully understand the trial requirements and risks, while improving efficiency and reducing errors in documentation. E-consent is particularly useful in remote or complex trials, offering real-time tracking, compliance, and audit-readiness, which enhances both participant engagement and trial management.
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How does e-consent improve participant engagement in clinical trials?
E-consent enhances participant engagement by providing interactive, user-friendly digital platforms that include multimedia elements such as videos and diagrams to explain complex trial information. Participants can review the consent forms at their own pace, access additional resources, and communicate with trial staff for clarification. This improved understanding of the trial details can lead to higher retention rates, as participants feel more informed and confident in their decision to take part.
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What are the compliance and regulatory benefits of using e-consent in clinical research?
E-consent platforms ensure compliance with global regulatory requirements by documenting the entire consent process, capturing digital signatures, and providing real-time audit trails. This transparency ensures that the correct consents are obtained for each stage of a trial and that no steps are missed. Additionally, e-consent platforms can facilitate re-consent when necessary, ensuring that any protocol changes are clearly communicated to participants and that their continued consent is recorded.
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How does e-consent streamline the re-consent process?
In clinical trials, re-consent may be necessary if there are protocol changes or new findings that affect participants. E-consent platforms streamline this process by enabling immediate communication with participants, offering updated consent forms digitally, and tracking their responses in real time. This eliminates delays and ensures that participants remain fully informed, compliant, and able to continue the trial without unnecessary interruptions or confusion.
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What are the cost-saving advantages of implementing e-consent systems in clinical trials?
E-consent systems reduce costs associated with paper-based documentation, printing, and physical storage. They also decrease the need for in-person consent procedures, which can be logistically challenging, especially in large-scale or decentralised trials. By automating consent tracking, reducing errors, and minimising the need for repeat consents, e-consent platforms improve overall trial efficiency, saving time and resources for both sponsors and clinical sites.
