ODM Compliance

The Clincial Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) was designed to provide a highly flexible means of exchanging and archiving clinical trial data. However, the model is now deployed across the clinical trial enterprise, being used in the configuration of EDC toolsets as well as providing the foundation of define.xml, the new, XML-based, mechanism for transmitting submission metadata to the Food and Drug Administration (FDA).

Companies using the standard want the assurance that they comply with the standard. Assero meets your needs by providing a cost-effective means by which companies can be assured that they meet the standard and will be able to communicate with partners without mishap.

Designed for tool vendors as well as CROs and pharmaceutical companies, the service combines the power of Assero's ODM tools ODMConform and ODMTest with on-site consultancy to provide you with a comprehensive evaluation of your toolset and infrastructure.

Assero will run a exhaustive series of tests to check the installation, record the results and detail any observations relating to best-practice, all documented in a final report. In addition, companies will also be provided with licences to use the Assero tools as part of their on-going testing.

To find out more, click here.