Quality and Compliance

RealWorld EDC is the only CDISC certified and FDA compliant electronic data capture system which has been specifically developed for post marketing surveillance studies. 

Quality Processes

CTEP’s processes and SOP's constantly undergo external audit by regulators and sponsors, and are also subject to our own rigorous controls.

Compliance

ICH E6 EC Clinical Trials Directive Japanese GPMSP, GVP, GPSP

RealWorld EDC is designed to be compliant with these regulations, in terms of system functionality, system support and the quality standards to which the system is designed, built, validated and maintained.

21 CFR part 11 ER/ES Guidelines

RealWorld EDC is designed to comply with industry requirements for security, data protection and information quality, including the FDA Code of Federal Regulation 21.11 and Japanese ER/ES Guidelines.

CDISC

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

Data protection

CTEP is compliant with European Data Protection Legislation and is registered with the Irish Data Protection Commissioner as a data controller and processor since 2002.

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