Late Phase Trials

eConsent – Electronic Informed Consent

eConsent is a secure Electronic Informed Consent solution designed to simplify, standardise, and digitise the patient consent process in late-phase clinical trials. By enabling electronic, multimedia-supported consent—both on-site and remote—eConsent improves patient understanding, accelerates enrolment, and ensures compliant, fully traceable consent management across global studies.

Key Benefits

1

Document Control

Reduces the risk of missing, duplicate, or outdated documents through centralised management.

2

Review Efficiency

Speeds up document review, approval, and retrieval by eliminating manual handoffs and silos.

3

Inspection Readiness

Maintains continuous inspection readiness with complete, current, and traceable documentation.

4

Cost Optimisation

Lowers operational and storage costs by replacing paper-based and fragmented document systems.

5

Standardisation

Applies consistent documentation standards across studies and sites, aligned with regulatory expectations.

6

Compliance Confidence

Strengthens confidence in regulatory submissions and inspections with audit-ready trial records.

Services Section

Key Functionalities

Consent Authoring
Supports digital creation and management of informed consent forms (ICFs) to ensure accuracy and standardisation.
Multimedia Support
Incorporates videos, visuals, and translated content to improve patient comprehension of study information.
Electronic Capture
Enables secure electronic consent capture for both remote and on-site patient participation.
Access Control
Applies role-based access for patients, investigators, and reviewers to protect confidentiality and accountability.
Version Management
Manages consent version control and re-consent workflows for protocol amendments.
eSignatures
Captures electronic signatures with complete, time-stamped audit trails.
Secure Storage
Ensures secure storage and rapid retrieval of consent records throughout the study lifecycle.
Automated Alerts
Triggers alerts for consent completion and re-consent requirements to prevent compliance gaps.
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faster consent completion and enrolment timelines

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reduction in consent-related errors and rework

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improvement in patient understanding and engagement

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auditable and compliant electronic consent records

Let's understand how you manage your Late Phase Studies?