eConsent

Datacubed's eConsent is a digital informed consent solution built for clinical trials, designed to transform one of the most critical moments in a study — the consent process — into a clear, human, and empowering experience. Rather than relying on dense PDFs and manual paperwork, Datacubed delivers a multimedia-rich, compliance-ready consent workflow that meets patients where they are, while giving sites, sponsors, and CROs the consistency and oversight they need.

Unlike standalone eConsent tools, Datacubed's solution is fully integrated within the same platform as ePRO, eCOA, and patient engagement solutions, keeping every part of the participant journey in one unified ecosystem. This integrated approach eliminates workflow fragmentation and supports a seamless experience from first consent through study completion.

Patient-Facing Features

• Video and graphics that simplify complex medical concepts for diverse audiences
• Plain-language explanations and translations that reflect global participants and varying literacy levels
• BYOD (Bring Your Own Device) access, allowing patients to review consent materials from the comfort of their own home and at their own pace
• Comprehension assessments that confirm genuine understanding, not just a signature
• An intuitive, familiar interface designed to feel supportive rather than clinical or intimidating

Site Benefits

• A single, centralised location to track every participant's consent status
• Fully paperless process — no filing cabinets, no manual reconciliation
• Clear, action-ready alerts to prevent missed or incomplete signatures
• Easy access to consent versions, updates, and amendment tracking
• Significant reductions in time and administrative burden associated with managing consent documents

Sponsor and CRO Capabilities

• Built-in compliance with 21 CFR Part 11, HIPAA, and GDPR regulations
• Secure, time-stamped audit trails for every consent interaction
• Standardised workflows deployable across multiple sites and countries
• Integrated recordkeeping that is always inspection-ready
• Reduced risk of consent deviations and discrepancies across the trial

Datacubed's eConsent is designed to set a positive tone for the entire study. When participants feel informed and supported from the outset, retention improves, protocol compliance strengthens, and the foundation for reliable data collection is established from day one. The platform is trusted by sponsors, CROs, and academic medical centres across a range of therapeutic areas, and is consistently praised for its ease of use, patient-friendly design, and responsiveness to site and sponsor feedback.