BEST PRACTICES: MDM Implementation - Journey Towards Golden Compliance
Senior Director Drug Development Information Governance, Janssen Research & Development LLC
Delivery Manager, Tata Consultancy Services
Janssen R&D is a worldwide leader in delivering innovative medicines for the treatment of an array of health concerns. In order to produce such medicines and achieve the ultimate goal of helping people live healthy lives, effective management of information assets must be in place. Clinical trials in R&D are prospective research studies, designed to answer specific questions about new treatments and are conducted under strict regulations and guidelines. Given the huge investment made in building and supporting processes to capture and maintain data, it is vital to establish consistency of business critical data in the clinical systems to create substantial strategic advantages via improved productivity and quality of core deliverables. MDM improves such data exchange between business functions and is fundamental in a data driven organization where analytics are a critical success factor. Governance with clear data ownership is critical, including well defined terms with business rules.
This presentation describes the various challenges and workarounds in the journey of MDM implementation at Janssen R&D. The pharma industry is known for frequent licensing agreements and, mergers and acquisitions. Along with these agreements, the processes and systems are also merged or integrated. However, the data sources remain in different formats. Here MDM can and should play a major role. While the pharma industry is slowly and broadly adapting MDM into business processes, Janssen R&D remains one of the pioneers. This team faced significant challenges while implementing the framework. Starting with a multi-domain MDM approach, the infrastructure evolved to a robust multi-tool environment and the team added a few skill centric roles along the way. The ultimate aim was to ensure the accurate data in one single format. Today, the MDM hub contains master data for multiple vital domains and is being used as the authoritative source for that data. Moreover, this master data and its related metadata is being consumed and used by various functions at Janssen R&D to increase the efficiencies of the clinical trial business process.
- Evolving from an initial implementation framework for master data management and governance to the current robust framework.
- Using increased efficiency of business processes and compliance to industry regulation and guidelines as the main drivers.
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