End-to-End RIM Data Management for a Large Pharmaceutical Company
IDMP Preparation and PMS Data Management for a Large Pharmaceutical Company
Project Summary
A large multinational pharmaceutical company with a broad product portfolio partnered with Celegence to ensure readiness for EU IDMP compliance. With EMA deadlines approaching, the client required a structured and comprehensive approach covering data foundation, remediation, and PMS data management. Celegence established a scalable framework that ensured consistency, completeness, and alignment across RIM, source documents, and EMA databases.
Scope of Work
Provided advisory consulting on EU IDMP requirements
Conducted data mapping, extraction, cleansing, and enrichment using structured methodologies
Standardized datasets using templates, dossiers, and document management tools
Extracted and validated data from SmPCs and Module 3
Compared RIM data against SPOR and other EMA vocabularies to identify and reconcile inconsistencies
Corrected missing or inaccurate entries in RIMS and ensured data completeness
Conducted PMS data analysis, corrections, and enhancements per EMA guidelines
Managed PMS verification, corrections, and updates via EMA Service Desk tickets and PUI change requests
Supported impact assessments following EEA/EU maintenance requests
Challenges Faced by the Client
Fragmented data across RIM, source documents, and EMA databases
Misalignment with SPOR and other EMA vocabularies
Inconsistent or missing data within RIMS requiring remediation
Complex PMS compliance requirements tied to evolving EU submissions
Tight timelines to achieve IDMP readiness before EMA deadlines
Project Achievements
Achieved full IDMP data readiness aligned with EMA expectations
Resolved data quality gaps across RIM, source documents, and PMS databases
Strengthened PMS compliance and minimized regulatory risks
Established a future-proof data governance framework for continuous IDMP and PMS management
Project Success
Celegence’s blend of regulatory expertise, structured data methodologies, and SME-led consulting enabled efficient collaboration and proactive issue resolution. By combining data integrity checks with strategic remediation, Celegence positioned the client for sustainable IDMP and PMS compliance..
Need Support for IDMP and PMS Data Compliance?
Celegence provides end-to-end services for data mapping, remediation, enrichment, and compliance management—helping pharma companies achieve IDMP and PMS readiness with confidence. 📧 Email us at info@celegence.com
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05 Nov, 2025
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