Medistat is a Solutions Provider for CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, Study/Trial Design Model standards. Medistat offers and recommends you to implement CDISC models in your data.
Clinical Data Interchange Standards Consortium
CDISC (Clinical Data Interchange Standards Consortium), is a global, non-profit organization providing standards for data collection and analysis in clinical and non-clinical uses. The standards are mandated for regulatory submissions to the U.S. FDA and to the Japan PMDA as well as to the European Innovative Medicines Initiative (IMI).
CDISC Foundational Standards are the basis of the complete suite of standards, supporting clinical research processes from the beginning until the end. Foundational Standards focus on the core principles for defining data standards and including models, domains and specifications for data representation.
The sponsors will submit clinical trials data using the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) format developed by the Clinical Data Interchange Standards Consortium(CDISC).
The CDISC services are an integrated part of the data management and include:
· Statistical programming using Analysis Data Model (ADaM) datasets as input for the production of statistical results.
· Clinical Data Acquisition Standards Harmonization (CDASH)
· Controlled Terminology
· Define-XML and Define-PDF
· Study Data Tabulation Model (SDTM) for annotated CRF and metadata
· Creation of documentation for integrated databases