eCRF

eCRF by Trialflare is an electronic Case Report Form solution designed for clinical trials, targeting sponsors, CROs, data managers, and site staff. It provides tools for form design, data capture, data integrity management, and reporting within a single modular platform that also covers EDC, CTMS, eTMF, ePRO, and wearable data collection.

The platform is built around a self-service model, allowing users to design, test, and launch their own eCRF without relying on vendor-managed build processes or incurring hidden fees. Training and support are included as part of the ongoing service.

Form Building and Configuration

• User-friendly form building tools for designing and launching eCRFs without vendor gatekeeping
• Comprehensive form logic, field validation, draft saving, and autosaving
• Rich data types to support varied data collection requirements
• Templates and repeat visit forms to reduce setup time
• Configurable workflows, form cloning, and study document management
• Repeat forms for multiple visits can be configured with a single action
• No hidden build costs; bespoke and custom configuration included upfront

Data Manager Controls and Security

• Role-based access (RBA) to restrict each user to specific action privileges
• Secure invitation of collaborators including sponsors, CROs, and site staff
• Single sign-on (SSO) with two-factor authentication (2FA) and password policy enforcement
• Full audit trails for traceability
• Compliance with 21 CFR Part 11, GDPR, HIPAA, and additional regulatory standards
• API and webhook capability to connect with external tools and resources
• Enhanced EDC functionality supporting web, wearables, smartphones, and ePRO

Integration and Interoperability

• All-in-one modular design bringing EDC, eCRF, CTMS, eTMF, ePRO, and wearables into a single platform
• Single portal covering all actions, roles, and responsibilities without fragmentation between components
• Webhook and API support for integration with existing tools
• Compatibility with OneDrive, Google Drive, and Dropbox, plus data export options
• Supports decentralized and hybrid trial models with online and offline data capture
• Accessible via smartphones, tablets, and laptops; supports offline PDF and DOCX generation

Data Integrity and Validation

• Real-time checks, prompts, and alerts during data entry to maintain accuracy
• Restrictions on data entry to specific ranges, values, and formats, with out-of-range submissions blocked
• Version control and audit logs for full data traceability
• System-wide alerts and queries to flag critical or unexpected values
• Data review assignment to medical monitors, project managers, PIs, Sub-PIs, and others
• eSource support at site level to reduce data redundancy and re-entry errors
• Single and bulk source data verification (SDV) available when eSource is not used

Queries and Reporting

• Customisable queries to bring relevant data to the attention of appropriate personnel
• Any number of queries can be added to a study
• Real-time data dashboard providing operational data, participant overviews, and adverse event reports
• Reporting designed to highlight trends and key data instantly
• Real-time data access reduces reliance on spreadsheet sharing and status meetings

Trialflare's eCRF is offered by Seastorm Limited and is suitable for a range of research types including Phase IV studies, real-world evidence, clinical and nutritional trials, and academic research. The platform supports decentralized and hybrid trial designs and is accessible across device types.