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 for biopharmaceutical R&D. It presents a framework-operating model that addresses governance of data in a more holistic way.