MAX KELLEHER¹, REMCO MUNNIK²
1. Chief Operating Officer, Generis, United Kingdom
2. a Director at Iperion, a Deloitte business, Netherlands

Abstract

Pharmaceutical companies recognize that the absence of standardized data can hinder their agility and innovation. This is particularly applicable to in-flight data, as it travels between different software solutions. Max Kelleher, Chief Operating Officer at Generis and Remco Munnik, a Director at Iperion, a Deloitte business, offer practical guidance on mapping and managing operational data to enhance business operations.

Leveraging live company master data more effectively and strategically, thereby creating a flow of broader data and insights between functions, will enhance a range of different use cases. Much of this ‘in-flight’ data is incidental information captured as part of a task, yet its value in providing oversight, traceability and impact assessment to senior management could be considerable – if only companies could find a way to harness and control it more systematically.

The handover of data between point software solutions – such as regulatory systems (RIMS), clinical trial management (CTMS), pharmacovigilance (PV) – is where gaps and discrepancies in information between systems occur, leading to operational blind-spots and strategic oversights at best, or regulatory incompliance at worst. This makes hard work of change management, and could mean that product development information, and patient safety events, aren’t fully traceable.

Overcoming the silos, interconnecting the data, and keeping those connections dynamic and smart, is the next big opportunity – and provide the key to using everyday operational data to drive ...