Tools & Software Used by CRCs

Electronic Data Capture (EDC) Systems

EDC systems have replaced paper CRFs in virtually all modern clinical trials. They are the primary tools CRCs use for entering, managing, and querying study data.

Leading EDC Platforms

• Medidata Rave: The most widely used EDC platform globally. Features include real-time data validation, edit checks, medical coding (MedDRA, WHO Drug), and integration with Medidata's broader clinical cloud suite.
• Veeva Vault EDC: A newer platform gaining rapid adoption. Cloud-native architecture with a modern, intuitive interface. Strong integration with Veeva's CTMS, eTMF, and quality management systems.
• Oracle Clinical One: An integrated platform combining randomization (RTSM), drug supply, and EDC. Used by many large pharmaceutical companies.
• Castor EDC: User-friendly, cost-effective platform popular in academic and investigator-initiated research. Offers eConsent and ePRO capabilities.
• REDCap: A free, open-source EDC tool developed by Vanderbilt University. Widely used in academic research and investigator-initiated trials. Not designed for registrational (sponsor-mandated) studies.
• Viedoc: A cloud-based EDC with strong user experience design. Growing presence in European clinical trials.

Key EDC Concepts for CRCs

• Data Entry: Entering data from source documents into the eCRF, following field-by-field completion guidelines.
• Edit Checks: Automated validation rules that flag inconsistencies (e.g., visit dates out of sequence, values outside expected ranges).
• Queries: Questions raised by data managers or automated systems about data discrepancies. CRCs must respond to queries promptly and accurately.
• Audit Trail: Every data entry, modification, and query response is logged with user ID, date/time, and reason for change — per 21 CFR Part 11 requirements.
• Electronic Signatures: Some data entries require electronic signatures with full name and date/time, meeting regulatory requirements for electronic records.