The global SAFE-BioPharma digital identity standard provides standardized ways to manage and verify digital identities and to apply legally binding digital signatures to electronic documents. It was developed by a consortium of biopharmaceutical and related companies with participation from the US Food and Drug Administration and the European Medicines Agency. The standard is managed by the non-profit SAFE-BioPharma Association.
CDISC is a global, open, multidisciplinary non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.