
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. Clinnovo 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.
CDISC Mapping Specifications
SDTM, ADaM Domain datasets generation
Comprehensive validation of SDTM and AdaM Datasets
Legacy Study conversion
Define.XML Document
ISS/ISE study standardization