Developing a Data Governance Framework for Global Pharma Clinical Operations

A global pharmaceutical company recognized the critical role of data in delivering patient-centered solutions and driving healthcare innovation. However, rapid advances in technology, increasing regulatory demands, and expanding data sources made it difficult to establish a cohesive and comprehensive approach to clinical data management. To address this challenge, the company sought to establish a data governance framework specifically tailored to its clinical operations and create a blueprint to guide future data governance initiatives across the organization. Through an in-depth process of stakeholder engagement, analysis, and strategy development, Astrix enabled the company to develop a future state landscape model and align on a supporting technology architecture and business glossary, which will support the company’s data-driven vision for the future.

Business Objectives

• For a global pharmaceutical company – establish a data governance framework for Clinical Operations that will be extensible to other areas
• Assess the current state of clinical operational data governance
• Draft a data governance policy for clinical operational data
• Define a future state data governance strategy and framework including strategy, organizational model, technology support, and business glossary
• Define an implementation roadmap to achieve the future state data governance strategy and implementation model that can be tailored and applied to remaining domains

Complete Results of Project

• Solidified a common understanding among cross-functional stakeholders regarding the current state data governance landscape and associated challenges
• Developed a data governance policy that outlines the strategic directive for treating data as a corporate asset
• Future State landscape, model, and how it applies to business processes
• Supporting technology needs and conceptual architecture
• Aligned on approach and secured buy-in from sponsors and stakeholders to execute the data governance plan
• Development of a business glossary

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, technology solutions, and people to the life science community. Through world-class people, process, and technology, Astrix works with clients to fundamentally improve business, scientific, and medical outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of fully integrated services designed to deliver value to clients across their organizations. To learn the latest about how Astrix is transforming the way science-based businesses succeed today, visit www.astrixinc.com.