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Introduction

In a world characterised by unprecedented generation, storage and utilisation of data on a massive scale, the biopharmaceutical industry has been compelled to adapt from the use of conventional paper-based processes, through electronic capture of discrete data, to the ability to receive, collect and analyse continuous data from multiple, remote, patient-managed devices.

 

This paper presents a high-level data governance framework, a SWOT analysis for data governance in biopharmaceutical R&D, and explores challenges in decentralised R&D clinical trials. Finally, an operating model framework is presented that addresses governance of data in a more holistic way that facilitates the development of a more robust and integrated design.

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Authors

Stephen Gunnigle

Aidan Walker

Dimitrios Alexopoulos

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- Published October 2023 - 

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