XBIOM Regulatory Submission

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

XBIOM™ serves both nonclinical and clinical data standardization needs, addressing the distinct requirements of CDISC SDTM SEND for nonclinical studies and SDTM/ADaM for clinical trials, making it a unified solution for organizations managing complex regulatory submissions across multiple study types.

Nonclinical Studies and SEND Capabilities

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

Clinical Study Data Standardization — SDTM and ADaM

• Ingests as-collected patient data from EDC systems and CRFs, as well as Biomarker Assay data from bio-banked bio-sample sources, through a virtual data room.
• Data is curated using XBIOM dashboards and auto-transformed by the Smart-Transformer (ST) into a meta-model Universal Data Model (UDM) repository managed within the XBIOM Clinical Data Repository (CDR).
• The Smart-Transformer leverages previously stored mappings from the Metadata Repository (MDR) library to auto-generate SDTM data sets using a selected Implementation Guide (IG) and Controlled Terminology (CT), both managed within the MDR.
• Authorized biostatisticians can use the UDM to read and interpret the Statistical Analysis Plan (SAP), search and find analysis-ready cohorts, and generate the flags needed to produce ADSL, BDS, and OCCDS ADaM files.
• Analysis-ready data is layered onto the UDM to create a Data Services Layer (DSL), with the UDM and DSL together forming the Clinical Data Hub (CDH) of the CDR.
• ADaM data sets can be prepared either using previously generated mappings in the MDR or through programmer-generated scripts using R, Python, or SAS within the Statistical Computing Environment (SCE).
• Tables, Figures, and Listings (TFLs) can be generated directly from the DSL using on-board statistical tools and custom scripts, or alternatively from ADaM data sets using traditional programming approaches.
• Includes tools for generating Trial Design domains, TS.XPT, and Define.XML for clinical submissions.

Platform Architecture and Compliance

• All data capture, transformation, and packaging operates under 21 CFR Part 11 records controls, ensuring regulatory-grade data integrity throughout the submission lifecycle.
• The platform integrates data from LIMS, EDC, and Specialty Assay Labs through a virtual data room, supporting end-to-end data ingestion and curation.
• The MDR is tightly integrated with the CDR, enabling consistent management of implementation guides, controlled terminology, and transformation mappings across both nonclinical and clinical workflows.