A Technology Assisted Approach for SDTM Specification and Program Generation

End-to-End SDTM artifacts management with advanced features.

Home /
Brain SDTM

About BRAIN SDTM

An advanced module designed to optimize the creation and management of SDTM artifacts in strict adherence to CDISC standards. Our automation is expected to produce a 50% reduction in effort, and 69% reduction in timelines for generation of outputs per study.

Benefits

Quickly identify and remove roadblocks, accelerating time to study completion

Learn more about the Pfizer & Saama partnership!

Features

Auto-generation of study SDTM specifications using standards

This feature group focuses on the automation of Study SDTM specifications generation by leveraging industry standards. It streamlines the process of creating study-specific SDTM specifications by adhering to established standards and guidelines, ensuring consistency and quality in data preparation for clinical trials.

Supports Latest Define-XML Version

This group emphasizes the platform’s compatibility and support for Define.xml. By aligning with the latest version, it enables seamless integration and compliance with regulatory requirements, facilitating efficient metadata management and submission processes.

Enhanced study-specific metadata and terminology support

This set of features emphasizes the system’s capability to handle study-specific value-level metadata, controlled terminology, methods, dictionaries, and comments. By providing support for tailoring these elements to individual studies, it enhances flexibility and accuracy in data representation and interpretation.

Global and study-specific transformation functions support

This highlights the platform’s ability to accommodate both global and study-specific transformation functions. It enables users to apply standardized and customized transformations to ensure data consistency and integrity across different studies, enhancing the adaptability and robustness of data processing workflows.

Standards management and customization features

Focusing on standards management and customization, this group includes tiered standard mappings, multiple versions of controlled terminology, value-level metadata management, standard transformation maps, and custom transformation maps creation. These features empower users to efficiently manage standards, adapt them to specific study requirements, and create customized transformation maps.