Patient Engagement

ClinVigilant Patient Engagement is a digital platform designed to support the conduct of clinical trials by managing the full patient journey within a single system. It is intended for use by patients, clinical sites, and sponsors, and covers key areas including electronic consent, patient engagement, and direct data collection. The platform supports both remote and on-site trial conduct, with tools for communication, compliance monitoring, and real-time data capture.

The platform aims to reduce operational costs by decreasing the number of physical site visits required, increase patient recruitment including from minority and diverse backgrounds, and lower dropout rates through automated remote data collection that reduces the burden on participants.

Core Platform Capabilities

• Digitises the clinical trial process for patients, sites, and sponsors
• Supports remote trial conduct and remote site-patient interactions via video and text chat
• Creates audit trails of every interaction and data exchange
• Provides real-time data, compliance, and status views across all relevant roles
• Facilitates remote monitoring of clinical trials
• Cloud-based infrastructure with support for mHealth applications and wearables

eConsent

• End-to-end digital consent workflow with layered and tiered consent options
• Patients can withdraw consent at any time
• Automated reconsent management with immediate alerts when new information becomes available
• Tracking and document version management
• Process administration flexibility supporting remote or on-site, digital or paper, and electronic or wet ink signature options
• Educational materials to support patient comprehension, including glossaries, videos, documents, and images with keyword tagging
• Knowledge and comprehension assessment of consent information
• Omnichannel communication for additional clarifications via text or video chat
• Auto-generation of eTMF-related logs and forms

Patient Engagement

• Visits management including calendar integration, visit preparation information, scheduling and rescheduling, alerts and reminders, visit completion tracking, out-of-window visit alerts, and unscheduled visit tracking
• Trial medication management including reminders, consumption data collection, missed dose alerts, and refill reminders
• Study-related activity management covering diaries, patient-reported outcome completion, dietary restrictions, and sample collection, with alerts, reminders, completion tracking, and missed activity alerts
• Auto-generation of eTMF-related logs and forms
• Trial-specific education including consent-related updates, current trial updates, and general information on clinical trials
• Compliance and motivation tools including gamification, status reports, in-app messages, site visit logistics management, and access to personal health data
• Secure omnichannel communication via text chat, email, in-app notifications, and video chat
• Standardised and tailored communication plans, progress and performance assessment, care instructions, wellness and prevention guides, and site team and services contact directories including nearest healthcare services such as pharmacies

Direct Data Collection

• Adverse event alerting from patient to investigator
• Patient-generated data capture including patient diaries, questionnaires (including quality of life), disease and behaviour management diaries, surveys, self-symptom assessments, images and videos, and end-of-trial surveys
• Data capture from devices, apps, wearables, and third-party sources such as laboratories
• Medication consumption data collection and reminders
• Care coordination features including between-visit telemedicine, virtual assistance and coaching, real-time direct data collection, and early detection of abnormalities

ClinVigilant Patient Engagement is delivered as a cloud-based platform and integrates with third-party data sources including laboratory systems and external devices. It supports electronic patient-reported outcomes and continuous data collection via wearables, and includes eTMF documentation capabilities to support regulatory compliance requirements.