The client is a Fortune 500 biopharmaceutical company that discovers, develops, and markets innovative medicines. Their products are known worldwide for the treatment of several serious diseases.
Challenge
IDMP (Identification of Medicinal Products) is a global regulatory standard that aims to establish a common data framework for medicinal products. All pharmaceutical companies marketing products in the EU are required to comply with this regulation, and agencies such as the FDA are considering adopting this standard too.
The client had set a goal for IDMP implementation once the new data model goes live in 2023 or early 2024. The client needed to optimize business processes around data collection, data quality, assessments and remediation, data governance and ongoing data management. However, getting ready for this massive compliance initiative would take away existing resources from other business priorities, and required massive cross functional collaboration.
Solution
This long standing Big Pharma client of Orion engaged us to lead the effort to assess the IDMP road map and lead the implementation. This was a two phased project. Phase one was to support the client’s readiness to comply with the IDMP requirements. The second phase was to implement a technical solution within the next 12 months (2024).
The first step was to perform data analysis and remediation, and then data migration. Orion identified integrations required to ensure completeness according to IDMP standards. We identified data gaps such as missing substances, vocabulary updates, and other required attributes.
To incorporate IDMP fields, the client expanded their Regulatory RIM platform and utilized Sporify for IDMP term translation. Orion set up a test environment for end-to-end data processing and validated configuration changes for risk and data integrity. We resolved data issues and provided recommendations for test environments and controlled vocabularies. We also implemented change management activities, including communication, training, and documentation updates. These actions enabled the client to streamline data management and prepare for IDMP implementation.
Impact
Orion was able to define the strategy for IDMP compliance and develop a road map for this Big Pharma client, moving them seamlessly to the next phase of implementation.
Orion’s recommendations, based on gap analysis and remediation approaches, positively affected the client’s IDMP road map:
- Ensured data readiness for implementation of IDMP standards
- Improved data consistency through standardizing and matching the source and target data contents
- Incorporated required IDMP attributes by successfully configuring and updating the client’s existing RIM system implementation
- Enhanced overall data quality, specifically in preparation for the subsequent phase of IDMP implementation
- Reduced the need for excessive regression testing, resulting in time and cost savings
