BRAIN

Saama's Biometrics Research and Analysis Information Network (BRAIN) is a centralized platform designed for statistical programmers and biostatisticians working in clinical trials and regulatory submissions. By consolidating all biometrics workflows into a single environment, BRAIN is built to accelerate submission timelines and reduce the complexity typically associated with managing study data, code, and artifacts across disparate systems.

BRAIN enables users to digitize study specifications, generate submission-ready tables, listings, and figures (TLFs), manage artifacts, and raise issues — all within one unified platform. Saama's proprietary knowledge graph automatically logs all changes to code and artifacts, ensuring full traceability and audit readiness throughout the entire analysis lifecycle.

Key Benefits

• Single environment: Manage data, statistical programming, artifacts, and metadata in one centralized location, eliminating the need to switch between multiple tools or systems.
• Full traceability: A complete audit trail and lineage of all analyses is maintained automatically, supporting regulatory compliance and submission integrity.
• Reusability: Leverage previously tested and validated artifacts and code, removing the need to recreate similar outputs from scratch and reducing redundant effort across studies.
• Collaborative workflows: Issue tracking is integrated directly at the artifact level, with automated notifications triggered when issues are raised, eliminating reliance on third-party applications or manual spreadsheets.

Core Capabilities

• Digitization of study specifications within the platform
• Generation of submission-ready TLFs (tables, listings, and figures)
• Artifact management with version control and change logging via a proprietary knowledge graph
• Integrated issue tracking and automated notifications at the artifact level
• Full audit trail and analysis lineage maintained automatically

BRAIN is part of Saama's broader Statistical Programming and Submissions suite, which also includes BRAIN SCE, BRAIN SDTM, BRAIN Visualization, and BRAIN Consortium. The platform is purpose-built for life sciences organizations seeking to streamline biometrics operations and meet regulatory submission requirements more efficiently.