Data Standardization
Overview
The Data Standardization project is taking practical steps towards developing data standard recommendations within the in vitro diagnostic ecosystem. Focusing on clinical study data for regulatory submissions, the project intends to align clinical diagnostic stakeholders around recommended data standards and work with standards organizations to build a library to support interoperability, gathering of evidence, and streamlining of the clinical study design process.
Data Standard Working Group
Active Data Standard Working Group members represent the following IVD stakeholders:
- Abbott
- BD
- Beckman Coulter
- CDISC
- Fujirebio
- NDA Partners
- Roche
- Siemens Healthineers
- Veeva
- FDA