Home Driving efficiency in Life Sciences business processes with standardised in-flight data
2023

Driving efficiency in Life Sciences business processes with standardised in-flight data

by cyb2025
M. Kelleher, R. Munnik
biotech
data management
life sciences
Ontologies
PHARMACOVIGILANCE
RIMS

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.

 

ABOUT THE AUTHOR

Max Kelleher is Chief Operating Officer at Generis and formearly the company’s Head of European Operations. He is passionate about providing a viable, pragmatic path for modernising enterprise information management in regulated industries. His close work with both pharma companies and specialist solution partners has afforded him deep insight into the critical modern-day challenges that traditional approaches to business processes and information use in complex industries like Life Sciences do not fulfil.

Remco Munnik is a Director at Iperion, a Deloitte business, and a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. He is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. Iperion, a Deloitte business is a globally-operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.

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