CDISC describes the ODM standard:

“ODM is a vendor neutral, platform independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. All of the information that needs to be shared among different software systems during the setup, operation, analysis, submission or for long term retention as part of an archive is included in the model.”

Learn more about CDISC ODM accreditation»

CTEP is listed as a Registered Solutions Provider on the CDISC website.