BRAIN SDTM

BRAIN SDTM is an advanced module from Saama designed to optimize the creation and management of SDTM artifacts in strict adherence to CDISC standards. It provides a technology-assisted approach for end-to-end SDTM specification and program generation, making it an essential tool for clinical programmers and biometrics teams involved in regulatory submissions.

By leveraging intelligent automation, BRAIN SDTM is expected to deliver a 50% reduction in effort and a 69% reduction in timelines for the generation of outputs per study, significantly accelerating the path to submission-ready data packages.

Key Benefits

• Accelerated SDTM delivery: Automation in mapping and code generation enables meaningful efficiency gains throughout the SDTM production process.
• Submission-ready SDTM: The platform produces submission-ready SDTM datasets and define.xml, saving significant time that would otherwise be spent manually processing data into target formats.
• Automated code generation: A metadata-based code generation capability allows users to update specifications and generate code as part of a fully integrated process, while retaining flexibility for study-specific needs.
• Improved compliance: Reusable standards reduce the need for manual edits, leading to fewer errors and stronger overall compliance with regulatory requirements.

Core Features

• Auto-generation of study SDTM specifications: Automates the creation of study-specific SDTM specifications by leveraging industry standards and guidelines, ensuring consistency and quality in data preparation for clinical trials.
• Support for the latest Define-XML version: The platform is compatible with the latest Define.xml version, enabling seamless integration with regulatory requirements and facilitating efficient metadata management and submission processes.
• Enhanced study-specific metadata and terminology support: Handles study-specific value-level metadata, controlled terminology, methods, dictionaries, and comments, providing flexibility and accuracy in data representation and interpretation tailored to individual studies.
• Global and study-specific transformation functions: Accommodates both global and study-specific transformation functions, allowing users to apply standardized and customized transformations to ensure data consistency and integrity across different studies.
• Standards management and customization: Includes tiered standard mappings, support for multiple versions of controlled terminology, value-level metadata management, standard transformation maps, and the ability to create custom transformation maps — empowering users to manage and adapt standards to specific study requirements.

BRAIN SDTM is part of Saama's broader Biometrics Research and Analysis Information Network (BRAIN) platform, which supports statistical programming and regulatory submissions. It is purpose-built for life sciences organizations seeking to reduce manual effort, improve data quality, and achieve faster, more compliant clinical trial submissions.