BRAIN SDTM

BRAIN SDTM is an advanced module designed to streamline the creation and management of SDTM artifacts, ensuring strict adherence to CDISC standards. This technology-assisted approach significantly reduces the effort and timelines required for generating outputs per study, with automation expected to cut effort by 50% and timelines by 69%.

Benefits of using this module include:

• Accelerated SDTM delivery: Automation in mapping and code generation enhances efficiency.
• Submission ready SDTM: Provides submission-ready SDTM and define.xml, saving time in data processing.
• Automated code generation: Metadata-based code generation allows for specification updates and code generation as part of an integrated process, offering flexibility.
• Improved compliance: Re-usable standards reduce manual edits, enhancing compliance.

Features include:

• Auto-generation of study SDTM specifications: Automates the creation of study-specific SDTM specifications using industry standards, ensuring consistency and quality in data preparation for clinical trials.
• Supports Latest Define-XML Version: Ensures compatibility with the latest Define.xml version, facilitating efficient metadata management and compliance with regulatory requirements.
• Enhanced study-specific metadata and terminology support: Handles study-specific value-level metadata, controlled terminology, methods, dictionaries, and comments, enhancing flexibility and accuracy in data representation.
• Global and study-specific transformation functions support: Accommodates both global and study-specific transformation functions, ensuring data consistency and integrity across studies.
• Standards management and customization features: Includes tiered standard mappings, multiple versions of controlled terminology, value-level metadata management, and the creation of standard and custom transformation maps, empowering users to manage and adapt standards efficiently.