Standardizing your clinical trial data facilitates regulatory submissions and compliance with reporting requirements

Data standards are crucial in clinical studies to contribute to the overall success of the clinical study and are essential to ensure consistency, quality, and efficiency of clinical study data across different studies and datasets. Adhering to standardized data formats and terminologies facilitates efficient data collection from EDC or CRFs, data management, statistical analysis, study reporting, and supports data integration and ensures compliance, regulatory requirements, and expectations.

Does your team have the expertise and bandwidth to standardize your clinical trial data? Let's Talk.

Data Standards Services

At Veristat, as a part of CDISC Standards (Clinical Data Interchange Standards Consortium), our Statistical Programming experts create the following domains, datasets, and define.xml:

Study Data Tabulation Model (SDTM) domains, standardized variables using controlled terminology
Analysis Data Model (ADaM) datasets, standardized variables using controlled terminology
Controlled Terminology used (e.g., SDTMIG Terminology, ADaMIG Terminology, etc.)
Clinical Data Acquisition Standards Harmonization (CDASH) CRF domain, standardized variables using controlled terminology when EDC is built at Veristat
Define.xml for SDTM and ADaM datasets and controlled terminology used in the study
Reviewer’s Guides for SDTM and ADaM datasets
Regulatory submission-ready package development