XBIOM Regulatory

XBIOM™ Regulatory Submission, developed by PointCross Life Sciences, is a comprehensive regulatory data standardization and submission platform designed for biopharma R&D teams managing both nonclinical studies and clinical trials. The platform supports all workflows, transformations, and harmonization required to standardize as-collected data sourced from LIMS, EDC systems, and Specialty Assay Labs, packaging it for regulatory submission under 21 CFR Part 11 records controls.

XBIOM Regulatory addresses the distinct requirements of nonclinical SEND submissions as well as clinical SDTM and ADaM dataset generation, providing an end-to-end solution for teams responsible for preparing, validating, and submitting study data to regulatory agencies such as the FDA and PMDA.

Nonclinical Studies and SEND Compliance

• Supports FDA-mandated standardization of nonclinical studies (initiated since 2018) to CDISC SDTM SEND standards and released versions of CDISC Controlled Terminology.
• Employs a highly automated, low-touch, no-code process to generate, validate, and verify the consistency of SEND datasets against GLP Study Reports.
• Includes tools to conduct complete reconciliation of the SEND dataset against digital tabulations of reported summary tables in the Study Report, as required by the FDA Technical Conformance Guide.
• Provides functionality to extract summary tables from Study Reports and capture required SEND metadata directly from those reports.
• Generates key submission artifacts including TS.XPT, trial design domains (TA, TE, TX, DM), and Define.XML files.
• Features a built-in eDataValidator to ensure SEND datasets meet all conformance rules, including FDA-stipulated business rules and PMDA rules for Define.XML.

Clinical Study Data Standardization: SDTM Generation

• Ingests as-collected patient data from EDC systems and CRFs, as well as Biomarker Assay data from bio-banked biosamples, through a virtual data room (VDR).
• Data is curated using XBIOM dashboards and auto-transformed by the Smart Transformer (ST) into a meta-model Unified Data Model (UDM) repository.
• The Smart Transformer leverages previously stored mappings from the MDR (Metadata Repository) library to auto-generate SDTM datasets using a selected Implementation Guide (IG) and Controlled Terminology (CT).
• Both the IG and CT are managed within the MDR, which is fully integrated with the Clinical Data Repository (CDR).
• The entire lifecycle of clinical data through the repository is managed within the XBIOM CDR.

Clinical Study Data Standardization: ADaM Generation

• The UDM serves the Smart Transformer and search query interfaces with curated as-collected data, enabling authorized biostatisticians to interpret the Statistical Analysis Plan (SAP).
• Biostatisticians can search, find, and generate listings for analysis-ready cohorts, and produce the flags required to generate ADSL, BDS, and OCCDS ADaM files.
• Analysis-ready data is layered onto the UDM to create a Data Services Layer (DSL); together, the UDM and DSL form the Clinical Data Hub (CDH) of the CDR.
• ADaM datasets can be prepared using previously generated mappings in the MDR, or via programmer-generated scripts using R, Python, or SAS within the Statistical Computing Environment (SCE).

Tables, Figures, and Listings (TFLs) and Submission Packaging

• TFLs can be generated directly from the DSL using on-board statistical tools, with the ability to add custom scripts for required tabulations, figures, and charts.
• TFLs can alternatively be generated from ADaM datasets using traditional programming approaches.
• Tools for generating Trial Design domains, TS.XPT, and Define.XML files are included for both nonclinical and clinical submissions.

XBIOM Regulatory Submission operates within the broader XBIOM™ Solutions Platform from PointCross Life Sciences, integrating with components such as the VDR, MDR, UDM, and CDR to provide a unified, compliant environment for regulatory data preparation. The platform is designed to meet the standards of major regulatory agencies including the FDA and PMDA, and supports data controls in accordance with 21 CFR Part 11.