Quality & Compliance

Compliance

CDISC ODM accreditation is your assurance not only of the quality of RealWorld EDC, but also that the data and metadata it generates will be readily interchangeable and manageable. It is designed to comply with industry requirements for security, data protection and information quality, including the FDA Code of Federal Regulation 21.11.

Quality Processes

CTEP’s processes and SOPs (standard operating procedures) have successfully undergone external audit by regulators and sponsors. CTEP is registered with the European Data Protection Commissioner as a data processor since 2002. CTEP processes and standard operating procedures (SOPs) have been externally audited by regulators and sponsors in addition to our own rigorous quality controls.

CDISC

RealWorld EDC is accredited by the Clinical Data Interchange Standards Consortium (CDISC) under its Operational Data Model (ODM) standard. This is your guarantee of interoperability with other systems. This standard is intended to ensure that data and metadata generated during clinical research can be efficiently managed, exchanged with partners and archived.

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»