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Case Study 4: Clinical & Regulatory Data Harmonisation

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Project Overview

A Life sciences organisation required harmonisation of clinical trial, regulatory, and product data to support IDMP-aligned submissions and internal analytics.

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Clinical & Regulatory Data Harmonisation

 Connecting Life Science Data Sources

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Business ObjectivesFeatures & FunctionalityData Governance & ComplianceData Quality & StandardisationData Integration & ConsolidationMaster Data Lifecycle Management

Business Objectives

  • Achieve SPOR data compliance
  • Improve submission accuracy and speed
  • Improve traceability from clinical data to marketed products
  • Eliminate data silos between Clinical and Regulatory teams
  • Enhance reporting accuracy
  • Enable scalable IDMP submission processes

Features & Functionality

  • SPOR data mapping and harmonisation
  • Automated referential data validation
  • EMA-compatible data structures
  • Clinical-to-product data mapping
  • IDMP-aligned product definitions
  • Automated data lineage tracking
  • Automated Validation Rules for Regulatory Consistency
  • Integration with Regulatory Affairs and Quality Systems

Data Governance & Compliance

  • Defined data ownership across Regulatory, Quality, and Manufacturing
  • Defined SPOR data stewards
  • Regulatory access controls
  • EMA and GDPR compliance alignment

Data Quality & Standardisation

  • Standardised product naming conventions
  • Controlled vocabularies enforcement
  • Referential data synchronisation
  • Automated completeness and consistency checks

 

Data Integration & Consolidation

  • Integration with RIMS and submission tools
  • Alignment of global and local regulatory data

Master Data Lifecycle Management

  • Controlled update and approval workflows
  • Audit logs for regulatory changes
  • Continuous monitoring dashboards

Project Timeline

1

Months 1-2

Data audit and SPOR data assessment

2

Months 3-6

Data cleansing, standardisation, and mapping

3

Months 7-12

IDMP model configuration and system integration

4

Months 13-16

Validation, testing, training, and deployment

Project Highlights

Milestones and Deliverables


  • Cleaned and IDMP-aligned product master dataset.
  • Data governance framework for long-term accuracy and compliance.
  • Regulatory-ready data model.
  • Integrated Regulatory and Quality data flows.
Post-launch support & training. Integrity checks & updates.
Measurable Success Metrics


  • 60% reduction in duplicate product records.
  • Improved regulatory submission readiness.
  • Increased data accuracy for reporting and analytics.
  • Faster response to authority data requests
 Ensuring trusted data without compromise.
Expected Sustainable Key Outcomes


  • Long-term IDMP compliance foundation
  • Enhanced decision-making with high-quality, structured data.
  • Scalable platform for partner engagement and automation.
  • Improved regulatory confidence
Enhanced digital processes, supporting future initiatives. 

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Whether you need a full data transformation or an ongoing governance framework, our solutions ensure trusted and structured data for better decision-making. Contact us today to discuss how we can optimise your business data.

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