AUSTIN, Texas & COPENHAGEN, Denmark--(BUSINESS WIRE)--CDISC announced a collaboration with A3 Informatics to create industry-standard Biomedical Concepts with the goal of supporting their awareness and encouraging their adoption in clinical research. CDISC Biomedical Concepts form a reference information model that standardizes clinical research concepts and their representation in underlying data models.
A3 will develop a tool that mines sources such as redacted define.xml files, which contain metadata from clinical studies. CDISC will then use the A3 toolset to curate this metadata to create industry-standard Biomedical Concepts, which will ensure consistency and efficiency across studies and throughout the clinical research lifecycle. A3 informatics will present the findings from this project at the CDISC Europe Interchange in April, as part of the CDISC 360 Update.
“This collaboration is another important step in CDISC’s efforts to facilitate end-to-end automation implementations by evolving our standards,” said Dave Evans, CDISC President and CEO. “We look forward to sharing these Biomedical Concepts with the CDISC community so that industry organizations can leverage them to drive operational efficiencies in their research.”
Biomedical Concepts have been part of the development of the A3 Informatics suite of tools; however, Dave Iberson-Hurst, founder of A3 Informatics believes that they should be a fundamental part of the clinical data lifecycle. “Using Biomedical Concepts ensures that we have a single source of truth in our data and removes the silos and complexities that have been preventing our industry moving forward and adopting new technologies.”
“We are really proud to be part of this work and to be able to show the value of BCs to the industry and academia, as the foundation for true end-to-end automation. It is also part of our mission as an organisation to support the implementation and use of CDISC standards,” stated Adam de Neergaard, A3 Informatics CEO.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. https://www.cdisc.org/
ABOUT A3 INFORMATICS
A3 Informatics develops ground breaking software for managing clinical data. The A3ccelerate tools are designed and created by CDISC experts to manage both sponsor and CDISC standards all in one place with a user friendly interface. You can try the A3 Community MDR for free here: https://www.s-cubed-global.com/products/a3-community-mdr