The Clinical Data Interchange Standards Consortium (CDISC), a global non-profit organization, develops data standards to streamline the exchange of clinical research data.
CDISC compliance of trial datasets is essential to meet certain regulatory requirements, facilitate data sharing and collaboration, and promote interoperability and data reuse.
Benefits of standardized datasets:
CDISC’s primary goal is to improve medical research by standardizing data. Standardized data became a compulsory FDA (Food and Drug Administration) and PMDA (Pharmaceuticals and Medical Devices Agency) requirement for the submission of all clinical trial data. Regulatory agencies such as Chinese National Medical Products Administration (NMPA) recommend CDISC standards for regulatory submission of clinical trial data. Compliance with CDISC standards facilitates the review process by regulatory agencies, speeding up approval timelines for new drugs and medical devices.
FGK supports you in incorporating SDTM and ADaM standards into your new trials and can convert previous trial data into CDISC compliant datasets.
At FGK, we understand that converting clinical trial data into a standardized format can be a complex and time-consuming process. That's why we offer a range of expert CDISC SDTM services to streamline your submission processes.
FGK`s data managers and statisticians can offer in-depth knowledge in CDISC standards to provide SDTM and ADaM programming and documentation: