eSource

RealTime-eSource is a cloud-based electronic source data capture solution developed by RealTime eClinical Solutions, designed specifically for clinical trials. It helps research teams improve data accuracy, reduce protocol deviations, and maintain regulatory compliance — all while minimising the administrative burden on clinical research coordinators and site staff.

Built for organisations that need reliable, audit-ready data captured directly at the point of care, RealTime-eSource replaces paper-based processes with a streamlined digital workflow that integrates seamlessly into existing clinical operations.

Effortless Data Capture

• Online and mobile eSignatures allow documents to be signed securely anytime, anywhere, eliminating the need for printing and scanning.
• Built-in data validation rules automatically catch errors at the point of entry, keeping data clean and reliable throughout the study.
• Automated data capture from external devices removes the need for manual entry, saving valuable time for clinical staff.
• Real-time audit trails provide complete data traceability, supporting inspection readiness and giving teams full confidence in their records.

Regulatory Compliance and Data Security

• 21 CFR Part 11 and GDPR compliance are built into the platform, ensuring adherence to strict industry regulations without additional configuration.
• Enforced access controls and role-based permissions guarantee data security and maintain clear user accountability across the study team.
• Version control ensures all users are always working with the most current documents, eliminating confusion caused by outdated versions.
• Electronic audit trails streamline regulatory inspections and simplify ongoing compliance processes.

Seamless Workflow and Usability

• An intuitive interface makes data entry straightforward, reducing errors and freeing up time for clinical staff.
• Native integration with RealTime-CTMS creates a unified workflow, enabling effortless study execution across the platform ecosystem.
• Reduced data management overhead allows teams to spend less time on administrative tasks and more time focused on patient care.

Key Benefits for Clinical Research Sites

• Better CRC management enables sites to handle a greater number of studies simultaneously.
• Built-in guardrails actively reduce protocol deviations and lower FDA audit risk.
• Cleaner, more accurate data is captured directly at the point of care.
• Less administrative burden translates to a stronger clinical focus across the team.

RealTime-eSource is a cloud-based solution that also complements other RealTime eClinical tools, including an integrated digital payments module for participant reimbursements and an eReg/eISF system for electronic document management and regulatory filing. Together, these tools form a comprehensive eClinical suite built for modern clinical research sites.