eSource

Advarra eSource is an electronic source data solution built specifically for research sites and site networks conducting clinical trials. It enables organisations to capture and manage study data digitally, facilitate remote workflows, and eliminate paper source documents and duplicative processes—all within a fully integrated, 21 CFR Part 11-compliant system. eSource is suited to sites of all sizes, including large sites conducting investigator-initiated trials (IITs), and is designed to reduce staff burden while improving data quality and operational efficiency.

Developed in close collaboration with top research institutions across the globe, Advarra eSource reflects real-world clinical research needs. The platform is part of Advarra Cloud, a next-generation, fully managed clinical research cloud environment built upon clinical research best practices to automate, connect, and expedite processes across the clinical trial lifecycle.

Consolidated Data Capture and Management

• Provides an integrated eSource platform for sites and site networks, including a full-featured site EDC for large sites running investigator-initiated trials
• Supports intuitive, quality-controlled data capture workflows with comprehensive remote monitoring capabilities
• Simplifies form building and data collection to streamline overall data management
• Allows integration with clinical trial management systems (CTMS) and electronic medical records (EMR)

Regulatory Compliance and Data Integrity

• Fully supports 21 CFR Part 11 validation and compliance through audit trails and secure electronic signatures
• Advarra provides services and precompiled validation materials to assist with initial validation and to ensure compliance is maintained through each system upgrade
• Investigators can easily identify and follow up on oversight tasks such as adverse events and lab results, then apply a Part 11-compliant signature to confirm oversight

Remote Monitoring and Site–Sponsor Collaboration

• Enables easy and secure setup of remote monitoring sessions for sponsors and monitors
• Reduces the need for onsite monitoring visits, lowering associated costs
• Simplifies sponsor support through streamlined remote workflows built directly into the platform

Productivity and Data Quality Improvements

• Supports data transfer into the system via a FHIR lab results interface
• Enables data export out of the system using a dedicated data export API
• Offers flexible form constraint options to enforce higher data quality at the point of capture
• Improves communication and data collection processes across site staff

Integration with Clinical Conductor CTMS

• Seamlessly exchanges study and patient information between eSource and Clinical Conductor CTMS
• Automatically sends completed eSource forms to initiate billing workflows in Clinical Conductor, ensuring visits are billed promptly and accurately
• Eliminates inefficiencies caused by using separate systems for CTMS and source documentation, reducing redundancy and saving staff time
• Also supports integration with OnCore CTMS

Partnership with IgniteData for Enhanced Data Connectivity

• Advarra has partnered with IgniteData, whose Archer platform connects Advarra eSource and EDC solutions with EHR systems and sponsor EDC systems
• This integration is designed to increase efficiency, improve data quality, and further reduce staff burden across the clinical research workflow

Advarra eSource is delivered as part of the Advarra Cloud platform, providing a fully managed, easy-to-use environment. The system supports ongoing community collaboration, inviting research institutions to participate in product development to help shape the future direction of the technology.