SDTM – Data Standards Implementation
Empower Your Clinical Trial With IDDI’s SDTM Expertise
The Clinical Data Interchange Standards Consortium’s (CDISC) Study Data Tabulation Model (SDTM) plays a crucial role in ensuring data consistency, quality, and interoperability, ultimately supporting more efficient drug development and regulatory decision-making processes.
At IDDI, we master CDISC standards, meticulously preparing your data for submission according to stringent requirements set forth by the FDA.
Your CDISC Registered Provider
Our clinical data management (CDM) experts drive excellence in CDISC SDTM compliance, efficiently developing eCRFs to CDASH standards and delivering data in SDTM format. With experience handling SDTM in more than 100 studies, you can trust our rigorous quality control and existing package verification to provide you with submission-ready data.
Unparalleled Clinical Trial SDTM Services
Our SDTM – Data Standards Implementation solution includes:
- Seamless mapping to SDTM standards
- Creation of meticulously annotated SDTM CRFs
- Expert creation of define.xml and define.pdf files from SDTM dataset definitions
- Rigorous validation of data and define.xml files to guarantee accuracy and compliance
- Development of comprehensive clinical data reviewer’s guide (cSDRG) for enhanced clarity and insight
- Integrated summaries of safety & efficacy (ISS/ISE)
- Dataset conversion specification files
- SDTM programming is done using SAS 9.4 (SDTMIG v3.3, SDTMIG v3.2, SDTMIG v3.1.3)
- SDTM programming template
- SDTM formatting work is highly automated (SUPP — generation, variable ordering and labelling, ISO 8601 [partial] dates, …)
- Pinnacle 21 Community is used to verify the SDTM is compliant using the latest validation engine available
- QC of datasets is done by double programming: independent re-programming of datasets with electronic comparison
- External data integration/reconciliation + dictionary coding integration handled via SAS (odbc, or snapshot files)
- EPOCH, –LOBXFL, AETRTEM are handled via study-specific algorithm
With IDDI by Your Side
Navigating the complexities of CDISC compliance and data standards implementation becomes an easy journey toward regulatory submission.