Standards Governance

XBIOM™ MDR &
Smart Transformer

Rigorously apply standards through a Centralized Metadata Repository (MDR). Automate transformations with Smart Transformers and validate with eDataValidator.

Request Demo

Comprehensive Metadata Management

A Metadata Repository (MDR) is a centralized system that stores all your standards, templates, mappings, and terminology in one reusable place. Instead of rebuilding everything for each study, you maintain a library of proven components that work across your entire portfolio.

⚙️

Ontology & Repository

Stores your CDISC standards (SDTM, ADaM, SEND), controls who can access what, and connects to your existing systems through standard APIs.

⚡

Smart Transformer

Automates the tedious work. It maps your source data to CDISC formats, generates Define.xml files, and handles different Implementation Guide versions automatically.

🛡️

eDataValidator

Checks everything against FDA, CDISC, and PMDA rules before you submit. It catches problems early, when they’re easy to fix.

Real Results

10 weeks EDC setup drops from 16-20 weeks to under 10 weeks
50% SDTM creation time cuts in half
70% Regulatory submissions accelerate by 50-70%

Xbiom Whisperer

Instead of learning complex query syntax, researchers ask questions in plain English.

# User Query

"What safety signals in our kinase inhibitor program?"

# Whisperer Action

Converts natural language into precise API calls against your governed data.

Why Customers Choose Xbiom™ MDR

1. Comprehensive Standards Integration

  • CDASH: Ensures uniformity and accuracy in data collection.
  • SDTM: Simplifies compliance with FDA/PMDA requirements.
  • ADaM: Supports standardized analysis datasets.
  • Controlled Terminology: Consistency across trials and regions.

2. Therapeutic Area & Indications

  • Tailored Standards: Support for oncology, cardiology, and more.
  • Customization: Definition of unique data collection standards.
  • Flexibility: Meet specific needs of each study.

3. Automated Workflows

  • Data Transformation: Streamlines raw data conversion to SDTM/ADaM.
  • Standardized Validation: Real-time compliance checks.
  • Submission Speed: Expediting the data submission process.

4. Robust Metadata Validation

  • Real-Time Checks: Minimizes errors as data is processed.
  • Custom Rules: Tailored validation for sponsor requirements.
  • Proven Success: Thousands of studies successfully submitted.

Business Benefits of Xbiom MDR

✓ Accelerated Time-to-Market
✓ Enhanced Data Quality
✓ Seamless EDC Integration
✓ Improved Collaboration
✓ Future-Proof Management
✓ Cost Reduction
✓ Streamlined Submissions
✓ Scalability for Global Ops

Ensure your data traceability, simplify your data management workflows, and manage your data transformations and metadata as they evolve over time with a one-truth, one-source approach.

cookie By using this website, you agree to our cookie policy Close