Table 1 - Production CDISC Standards Primary Standard Description Versions and Release Dates SDTM
Study Data Tabulation Model, 3.
Comes configured with the CDISC SDTM
domain model as a base configuration, serving as a reference point for organizations without clinical data standards in place.
Comprehend Systems has created ready-to-use cloud-based version of Comprehend Clinical that enables study teams to easily visualize and analyze clinical data from any system, including Medidata Rave, Oracle Clinical, CDISC SDTM
or any other commercial or proprietary data source.
PointCross will standardize non-electronic submissions from PDF, non-standardized electronic and CDISC SDTM
formats into CDISC SEND or extended data representations for studies that do not fit within prevailing standards.
1 to any SDTM
data source and easily configure new SDTM
DATATRAK is a leader in driving standards compliance with a total of six registrations- CDASH, LAB, ODM, SDTM
Pre-built CDASH forms for 17 standard SDTM
June 4 - 5, 2013: 2-day SDTM
Theory and Application
Leveraging Medidata Services expertise in standards support, the solution includes CDASH forms for 17 standard SDTM
domains, Medidata Rave dictionaries using CDISC controlled terminology, and Rave edit checks and custom functions that help to enforce the SDTM
JMP Clinical uses SDTM
[Study Data Tabulation Model] data - the most mature CDISC data standard - and is one of the first tools to use the new ADaM data standard for analysis and reporting.
There is complete implementation of SDTM
compliance checks and ADaM (Analysis Data Model).
is the standard for clinical data tabulations, and is specified through the FDA electronic Common Technical Document (eCTD) Guidance as the model for submitting clinical data to the FDA in support of marketing applications.