It empowers users to drive data quality through the standardization and reuse of metadata. Based on CDISC standards, Formedix On facilitates regulatory compliance with the FDA, PMDA, EMA and other regulators.
With Formedix On you can:
Support for industry standards such as SDTM, ADaM, SEND, Define-XML, Analysis Results Metadata, Dataset-XML and ODM comes built in. In fact, Formedix have been active members of CDISC since 2001 and our products are CDISC certified.