eSource

eSource is an electronic data capture (EDC) and eCRF tool developed by Trialflare, designed for clinical trial sites that need to move away from paper-based processes. It is built for a broad range of stakeholders — including site staff, sponsors, CROs, principal investigators, and medical monitors — and consolidates EDC, eCRF, CTMS, eTMF, ePRO, and wearable data into a single platform.

The platform supports one-off, longitudinal, and ad-hoc data entry across a wide variety of data types, and is designed to reduce fragmentation caused by multiple portals and logins across clinical trial operations.

Form Building and Data Entry

• Create any number of forms for any purpose, including meeting notes, appointment information, email and SMS transcriptions, and clinical data outcomes.
• Supports one-off, longitudinal, and ad-hoc data entry modes.
• Includes comprehensive form logic, field validation, draft saving, and autosaving.
• Offers rich data types to accommodate varied data collection needs.
• Templates and repeat visit forms reduce setup time; repeat forms for multiple visits can be configured with a single click.
• Workflows can be configured, and forms and study documents can be cloned for reuse.

Role-Based Access and Security

• Role-based access control (RBA) restricts each user to specific action privileges.
• Supports secure invitation of collaborators including sponsors, CROs, and site staff.
• Single sign-on (SSO) with two-factor authentication (2FA) and configurable password policies.
• Full audit trails are maintained across the platform.
• Compliant with 21 CFR Part 11, GDPR, HIPAA, and additional regulatory standards.

Interoperability and Integration

• All modules — EDC, eCRF, CTMS, eTMF, ePRO, and wearables — are designed to communicate within a single platform, eliminating data fragmentation.
• Webhook and API capabilities allow integration with external tools and existing workflows.
• Supports integration with OneDrive, Google Drive, and Dropbox, as well as data exports.
• Compatible with web, smartphones, tablets, laptops, and wearable devices.
• Supports both online and offline data capture, with the ability to generate offline PDFs and DOCX files when needed.
• Designed to support decentralized and hybrid trial models.

Data Integrity and Validation

• Real-time checks, prompts, and alerts guide data entry and flag issues as they occur.
• Data entry can be restricted to specific ranges, values, and formats, with out-of-range submissions blocked.
• Version control and audit logs provide full traceability of collected data.
• System-wide alerts and queries can be generated automatically to highlight critical or unexpected values.
• Data can be assigned for review to medical monitors, project managers, PIs, Sub-PIs, and others.
• For sites using eSource directly, the platform reduces data redundancy and the risk of errors from re-entry; single and bulk source data verification (SDV) is also available for sites not using eSource.

Queries and Reporting

• Customisable queries can be added in any number to bring relevant data to the attention of appropriate personnel.
• A real-time data dashboard provides operational data, participant overviews, adverse event reports, and more.
• Real-time reporting reduces reliance on spreadsheet sharing and minimises time spent in data review meetings.
• Reports are designed to support data integrity monitoring and participant safety oversight.

Trialflare's eSource is developed by Seastorm Limited and is available to academic and commercial research organisations. The platform offers an academic partnership programme and supports a range of study types including Phase IV studies, real-world evidence (RWE), and clinical and nutritional trials.