eSource

Clinion eSource is an electronic source data capture solution designed for clinical trial sites, sponsors, and CROs. It enables site personnel to enter trial data directly into a secure mobile application at the point of care, replacing manual paper-based processes and eliminating the need for duplicate data entry. The result is a single, auditable source of truth where every data point is timestamped, traceable, and ready for regulatory review.

The platform addresses common bottlenecks in clinical trials — transcription errors, missing information, lengthy data cleaning cycles, and compliance challenges — by capturing data electronically at the moment of collection and syncing it in real time with connected systems including EDC platforms.

Core Capabilities

• Direct Data Capture (DDC): Site personnel enter trial data directly into eSource-enabled devices at the point of care, ensuring each entry reflects the exact context in which it was collected.
• Real-time EDC integration: eSource forms sync directly to the EDC in real time, removing the need for manual mapping and maintaining consistent data flow across systems.
• Automated data validation: Built-in validation checks flag data quality issues as they occur, reducing the volume of queries and the time spent on data cleaning.
• Audit trails and version control: Every entry is electronically logged with timestamps and full version history, supporting traceability throughout the trial lifecycle.
• Configurable user permissions: Access and editing rights within the platform can be controlled at a granular level, supporting both security and regulatory compliance.
• Easy-to-use interface: The interface is designed to simplify data entry and navigation, reducing errors and minimising the training required for site staff.
• Offline data entry: Site teams can capture data without an internet connection; entries automatically sync with the EDC once connectivity is restored, supporting data collection in remote locations or during outages.
• Remote monitoring and oversight: Sponsors, CRAs, and Principal Investigators can access and review trial data from any location, enabling remote source data verification and reducing the need for on-site visits.

Workflow Steps

1. Instant data entry: Site teams capture data directly into the system at the point of care, eliminating transcription delays.
2. EDC synchronisation: Captured data flows directly into the EDC in real time without manual transfer or mapping.
3. Regulatory-ready logging: Each entry is time-stamped, securely logged, and fully traceable for compliance purposes.
4. Remote access and oversight: Sponsors and CRAs monitor data remotely, enabling faster decision-making and targeted risk-based monitoring.

Regulatory Compliance

• Fully compliant with FDA 21 CFR Part 11, GDPR, and ICH-GCP requirements.
• Supports inspection readiness through secure user access controls, automated audit trails, time-stamped entries, and version control.
• Designed specifically for clinical trial data capture in accordance with GCP standards, distinct from general-purpose EMR systems.

Integrations and Suite Compatibility

• Integrates with Clinion EDC and can connect with other clinical trial systems to reduce manual data transfers and support a single source of truth.
• Part of Clinion's broader suite of clinical trial solutions, which includes RTSM, eProtocol, ePRO, eConsent, CTMS, CSR Automation, and eTMF.

Clinion eSource is built under the company's Responsible AI principles, with stated commitments to accountability, transparency, privacy and security, reliability and safety, and fairness across its AI-enabled tools.