Data collected across different phases of clinical trials now are required to follow CDISC standards, to be submitted to the US Food & Drug Administration (FDA) and the Japan Pharmaceutical and Medical Devices Agency (PMDA). Cytespace strongly believes in implementing requisite standards across the trials that we are a part of, to ensure increased efficiency and data quality. The team at Cytespace is highly experienced and passionate at implementing CDISC standards and have streamlined processes to do the same.
One of the challenging approaches for preparing the CDISC-compliant data is the need to convert the legacy data to create the CDISC-compliant data. Cytespace with its rich experience aims to provide guidance for regulatory submission and help execute data conversions.