CDISC Services

CDISC Services

CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation

CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.

ClinAsia has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.

At ClinAsia the first step in the CDISC mapping specification document service employs the comparison of the study metadata on par with the SDTM domain metadata. In complex studies where the CDM metadata was most suitable to the maximum extent possible with SDTM metadata, it is recommended to make use of automated mapping as a first step. Then If CDISC standard data sets and variable names were properly arranged in the CDM data sets, it is more suggested to use a data step or SQL select to verify for direct matches and document then so that the validity of the mappings can be mapped. This procedure only serves as a first step of SDTM metadata mapping, but it can purposefully eliminate hours of manual mapping. If the CDM metadata is not mapping with the SDTM metadata or if SDTM specifications were improperly used, then auto mapping is suggested to be avoided as the best choice

The successive step at ClinAsia in this service area employs manual mapping of the study data sets to the actual domain data sets and then there by mapping each single variable to the appropriate domain. Varying on how the CDM data is structured, you may have a facility to map each CDM file to every suitable single domain, and ensure a split its variables among multiple domains, or a combination of variables from multiple CDM files into a single existing domain. There are many types of variable mapping possible.

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