EDC Connect

EDC Connect, developed by RealTime eClinical Solutions, is a purpose-built integration solution that eliminates duplicate data entry for clinical research sites. By bridging the gap between eSource and sponsor-provided Electronic Data Capture (EDC) platforms, EDC Connect allows site teams to enter patient data once and automatically transfer it to any ODM-compatible EDC system — within minutes. It is designed for clinical sites that are burdened by the time-consuming and error-prone process of manually retyping data from eSource into EDC platforms.

According to RealTime's own reporting, clinical site teams spend an average of 20 minutes per visit on transcription and data cleanup alone. This manual process contributes to transcription errors, delayed patient safety data, increased queries, and slower study closeouts. EDC Connect was built specifically to solve this problem — delivering what the industry has long needed but lacked.

How EDC Connect Works

1. Import: Bring in the study design from the sponsor's EDC using the CDISC ODM standard, establishing the framework for data mapping.
2. Map: Quickly match eSource forms to the corresponding EDC fields using the intuitive Form Builder tool, streamlining the configuration process.
3. Export: Automatically send clean, mapped ODM files directly to the sponsor's EDC system, completing the data transfer without manual re-entry.

Key Benefits and Capabilities

• Enter data once in eSource and allow EDC Connect to handle all subsequent data transfer automatically.
• Minimize transcription mistakes that commonly arise from manual re-entry processes.
• Shorten study timelines and enable faster query resolution by reducing data lag.
• Fully aligned with 21 CFR Part 11 regulatory requirements, ensuring compliance for electronic records and signatures.
• Compatible with leading EDC platforms including Medidata Rave, Oracle Inform, and other ODM-compatible systems.

EDC Connect is the only solution of its kind to deliver true eSource-to-EDC automation, making it a critical tool for sites looking to improve operational efficiency, data quality, and regulatory compliance across their clinical trial portfolio.