eConsent

YPrime eConsent is a purpose-built electronic informed consent platform designed for sponsors and CROs running global clinical trials. It addresses one of the most persistent challenges in clinical research — enrollment delays — by streamlining the informed consent process from first consent through study closeout. With nearly 40% of all trial spend tied to recruitment and more than two-thirds of sites failing to meet enrollment goals, YPrime eConsent is engineered to reduce friction for both participants and sites while maintaining regulatory confidence and data integrity throughout the trial lifecycle.

The platform combines intuitive design, global compliance support, and built-in real-time assistance to help clinical trial teams improve participant understanding, accelerate enrollment, and support site workflows with consistency. The result is a faster, more reliable trial startup without compromising regulatory expectations.

Core eConsent Capabilities

• Dynamic, multimedia consent content: Deliver interactive content that clearly explains trial requirements, expectations, and risks, supporting truly informed consent and improving participant comprehension.
• Multi-device accessibility: Enable participants to review and complete electronic consent on mobile, tablet, or desktop devices, in their own language and at their own pace.
• Built-in real-time support: Provide participants and sites with immediate assistance during the consent process, reducing delays, minimising site workload, and preventing incomplete or incorrect submissions.
• Secure, encrypted data storage: All data within the platform is encrypted, ensuring participant information is protected at every stage of the trial.
• Complete version history and audit trails: Every version change is stored, providing a comprehensive record for compliance needs and regulatory audits.
• Inspection-ready documentation: The platform is designed to keep sponsors and CROs inspection-ready at every phase of the study, supporting evolving regulatory requirements across global regions.

Seamless Re-Consent Management

• Instant deployment of new consent versions: When protocols change, updated consent forms are deployed immediately while outdated versions are automatically retired, eliminating the risk of sites using incorrect forms.
• Targeted participant flagging: Only participants impacted by protocol changes are flagged for re-consent, allowing sites to focus their efforts where they are most needed.
• Real-time progress tracking: Re-consent progress is monitored in real time with complete audit trails, giving sponsors and CROs full visibility into compliance status across all sites.
• Participant-friendly re-consent experience: Participants can clearly see what has changed, review updates, and re-sign from any device, anywhere, reducing confusion and operational disruption.
• Elimination of manual re-consent risks: The digital workflow removes the missed signatures, outdated form versions, and manual tracking that introduce unnecessary risk in paper-based processes.

Regulatory Compliance and Data Integrity

• Designed to support compliant and ethical informed consent across global clinical trials, accommodating evolving regulatory requirements across multiple regions.
• All platform data is encrypted, and every version change is stored to meet future compliance needs or audit requirements.
• Supports inspection readiness at every phase of the study, from initial enrollment through study closeout.

YPrime eConsent integrates compliance, participant engagement, and operational efficiency into a single platform, making it a comprehensive solution for sponsors and CROs seeking to simplify enrollment, manage re-consent digitally, and run clinical trials with greater certainty and regulatory confidence.