Electronic Data Capture (EDC)
Streamline Data Collection, Management, and Compliance
Integrated with OnCore CTMS and equipped with a lab results interface via FHIR, our electronic data capture (EDC) system helps streamline workflows and ensure data integrity.
The system has helped us improve our data collection processes and helped to make communication more effective. The different options for building form constraints has helped us to ensure higher data quality.
Courtney Kennedy DNP, RN-BC
Manager, Clinical Trials Applications, University of Nebraska Medical Center
Streamline data collection and management using Advarra EDC, an electronic data capture system integrated with OnCore.
Learn More About EDC
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Enhance 21 CFR Part 11 compliance
Ensure data security and integrity using audit trails and secure signatures to fully support 21 CFR Part 11 validation and compliance. Advarra offers services to assist validation and materials to ensure validation is maintained throughout each upgrade.
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Streamline workflows with data transfer interfaces
Facilitate data transfer into the system using our FHIR lab results interface and out of the system using our data export API.
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Minimize duplicate data entry with OnCore CTMS integration
Take advantage of integration with OnCore CTMS to pull information related to organizations, protocols, and subjects.
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Benefit from the knowledge of the Onsemble Community
The system was developed in close collaboration with top research institutions across the country, ensuring it meets the research community’s needs.
Efficiently Implement and Validate your Advarra Technology
Reduce System Validation Burden with Advarra Validation Support
At Advarra, we’re committed to setting up our customers for success in the highly regulated clinical research environment. While the implementing organization is ultimately responsible for validation, we aid your path towards validation within our Part 11-compliant systems, Advarra EDC, eSource, eReg, and eConsent. Our approach ensures rapid time to value through implementation, integration setup, validation, and migration to establish a centralized source for your data and documents.
A Purpose-Built Clinical Research Cloud Platform
Built upon clinical research best practices, Advarra Cloud is a next-generation platform delivering applications in an easy-to-use, fully managed environment. Learn how the Cloud can help you automate, connect, and expedite processes across the clinical trial lifecycle.
Wayne State University Streamlines Compliance With Validation Services for Advarra EDC
EDC FAQs
What makes EDC a good fit for me?
The system is designed to serve the academic research community to help address the complexities when running investigator-initiated trials. In addition, Advarra EDC is 21 CFR Part 11-compliant, integrates with OnCore CTMS, and offers a lab results interface via FHIR.
Who hosts EDC? Does my IT team need to be involved?
EDC is an easily accessible, cloud-based, Advarra-hosted solution. Because Advarra hosts the system, very few IT and administration resources are required. To maximize your ad-hoc reporting capabilities, you may need a dedicated report writer.
How can I validate the system?
To efficiently implement EDC, validate your instance, and develop processes to maintain your EDC validation for each new protocol and system upgrade, Advarra developed a robust implementation and validation service. Our holistic approach encompasses implementation and initial validation.
