Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that defines and manages industry level platform-independent data standards that are widely used during the analysis, reporting and the regulatory submission of clinical data. For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files. At Quanticate we offer a range of CDISC Services and are experienced in mapping to CDISC Standards.
Quanticate has extensive experience in helping its customers become CDISC compliant. We have worked on large and small CDISC specific projects, some involving only consultancy and others involving mapping of multiple studies to CDISC standards.
OUR SERVICES INCLUDE:
As experts in the mapping of clinical and research data, Quanticate can ensure a successful mapping strategy is put into place and then delivered.
We are able to advise and provide services in relation to data integration and data conversion of data to SDTM and ADaM formats.
Quanticate have been involved in a number of successful mapping projects for submission, reports, or publication purposes. Our CDISC working group has experts that are actively involved in CDISC User Groups and that ensure all programmers have been trained in CDISC.
RECENT EXAMPLES OF MAPPING PROGRAMS INCLUDE:
Our large, global scale enables us to provide expertise and support to meet your needs in an efficient and high-quality way. Your data is the most important outcome of your clinical trial and is the result of a huge amount of investment - make sure you maximize it to its full potential.