Electronic Data Capture (EDC)
Streamline data collection, management, and compliance with EDC
Integrated with OnCore CTMS and equipped with a lab results interface via FHIR, our EDC system helps streamline workflows and ensure high 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 MSN, RN-BC
Manager, Clinical Trials Applications, University of Nebraska Medical Center
Learn more about EDC
Enhance 21 CFR Part 11 compliance
Ensure data security and integrity using audit trails and secure signatures to fully support validation and compliance with 21 CFR Part 11. Advarra offers services to assist validation and materials to ensure you maintain your validation throughout each upgrade.
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.
Minimize duplicate data entry with OnCore CTMS integration
Take advantage of integration with OnCore CTMS to pull information related to organizations, protocols, and subjects.
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 needs of the research community.
Efficiently Implement and Validate your Advarra eReg or EDC Instance
Reduce System Validation Burden with Advarra Technology Validation Support
At Advarra, we’re committed to setting up our customers for success in the highly regulated clinical research environment. While validation is ultimately the responsibility of the implementing organization, we aid your path towards validation within our Part 11-compliant systems, Advarra EDC and Advarra eReg. Our approach ensures rapid time to value through implementation, integration setup, validation, and migration to establish a validated, centralized source for your data and documents.
What makes EDC a good fit for me?
The system is designed to serve the academic research community to help address the complexities you face running Investigator Initiated Trials. In addition, EDC is validation-ready and fully supports compliance with 21 CFR Part 11, 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 has developed a robust implementation and validation service. Our holistic approach encompasses implementation and initial validation.