CDISC

CDISC Foundational Standards form the basis of a comprehensive suite of standards, supporting clinical and non-clinical research processes from start to finish. These standards focus on core principles for defining data standards and include models, domains, and specifications for data representation.

Therapeutic Area (TA) Standards build upon the Foundational Standards to represent data specific to certain disease areas. TA Standards include disease-specific metadata, examples, and guidance on implementing CDISC standards.

CDISC Standards define how to structure data but do not dictate what data should be collected or how to conduct clinical trials, assessments, or endpoints.

Neoclinus has a strong track record in providing CDISC solutions and is a CDISC Registered Solutions Provider. We have converted more than 20 studies as part of NDA submissions, all of which have been accepted by the FDA. The Clinical Data Interchange Standards Consortium (CDISC) developed the SDTM and ADaM models to standardize data structures for the submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities, including the FDA.

Neoclinus’s expert team possesses a strong technical understanding of both the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM), along with the corresponding implementation and Reviewer’s guides, CDISC terminologies, and related regulations.

We leverage our product development expertise at Neoclinus to deliver productivity improvements using in-house data definition templates and tools for mapping data to the SDTM format. Our robust SAS team develops macros to facilitate easier data conversions, reducing work by 20% to 40% and enabling faster delivery to our customers.

Additional we do

Also Provides CDISC Trainings to industry people.

Industry oriented CDISC SDTM and ADaM Training

We have well-defined SOP to data integrations and standardizations.

We provide defined data definitions and In-house macros, intended to give faster results with good quality.