Streamline CDISC Electronic Data Submissions: Technology Solution for CDISC PK Study Data

Through our collaborations with regulatory agencies, and partnerships with major global nonprofits, we, at Certara, continuously strive to provide up-to-date solutions to help streamline the drug development process for our clients. Beginning at the end of 2016, in a continuing effort towards international harmonization across regulatory agencies, the US Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory agencies, will require the mandatory submission of electronic pre-clinical and clinical data using CDISC standard formats. Other regulatory agencies, including the European Medical Agency (EMA), Korea Ministry of Food and Drug Safety (MFDS) and China Food and Drug Administration, are also considering the use of CDISC standards.

The Clinical Data Interchange Standards Consortium (CDISC) is a global, multidisciplinary,  non-profit organization that has established standards to support the acquisition, exchange, submission and archive of pre-clinical and clinical data. Since its formation in 1997, the CDISC mission is “to develop and support global, platform-independent data standards that enable information system interoperability, to improve medical research, and related areas of health care”. CDISC provides data standards for the entire clinical trial process, from source to analysis/reporting and culminating in regulatory submission. This includes standards for Trial Design and Protocol Information, CRF and Subject Data, Analysis Datasets and Regulatory Submissions.

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