Focus on in-flight data management delivers optimum business process control

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. The first phase is to identify where key data is generated, and how the supply and demand of that data looks across the ‘chain of custody’, as that data is re-used in different ways. Then a plan can be devised for improving the connection and flow of more unified data across departmental divides.

For young biotech companies starting from scratch, there is a clear opportunity to establish clean, consistent and definitive data from the outset, whereas for larger and more established companies the best options may be around intelligently mapping existing data sources and data flow. Then interconnections and interdependencies can be identified and managed more effectively, until such time as data remediation and end-to-end standardisation can be achieved.

It’s in this context that leveraging Ontologies is attracting interest – allowing inconsistently-formatted data to coexist, while recognising that the items referenced are the same, and linked. This is a useful first step in the move to treat all data as one joined-up resource, so that it can drive new actionable insights, decisions and processes.

Ontologies, now being championed through the Pistoia Alliance Ontologies Mapping project (a non-profit initiative), offer a practical middle ground. They allow companies to assess the diversity in their current data estate, and arrive at a workaround wherever the legacy complexity is too great to tackle straight off.

Considerations for in-flight data transformation  

With all of this in mind, here are some considerations and tips for tackling data transformation.

Unless the company is a young biotech with a largely greenfield tech set-up, large legacy systems, vast volumes of data, and the variable quality and availability of that data, will make it hard to know where to start. Rather than try to tackle everything everywhere all at once, the prudent choice involves identifying some tangible gains from higher-quality, interconnected data which, once cleaned and combined, will tell a fuller story.

That might be linking supply chain data to Regulatory data, to enable serialisation, (semi)automated batch release, and mitigation of shortage reporting, for instance. Or perhaps the aim is to shave a week off clinical development timescales, or complete eCTD applications or submit variations more speedily.

Promoting the value of data

It is only through visualising the current spread of information assets and associated use cases that companies will appreciate the potential for greater uniformity and fluidity of data use between the different departments. An effective map will chart where given data is used, and who is using it, along a process including creation, modification, and re-use by different teams and systems.

While some arguments favour a strong sense of data ownership within specific functions, it can be more powerful to encourage everyone across the company to buy into the value of consistent data so that all functions and teams play their own part in keeping data clean, compliant, comprehensive and current. Adopting an agile mindset is also about being prepared to try something, fail at it, learn from that and move forward.

Starting with regulatory standards

Regulators, through their adoption of data standards, are championing global identifiers for medicinal products and their active substances. Life Sciences companies that are inventing and developing these products and substances would benefit greatly from adopting data standards consistently from early development, and throughout their marketing authorisation/registration information and variations submissions.

Life Sciences companies have a real opportunity to enhance their operations by adopting these standards internally. This enables seamless transmission of consistent and dependable data across processes. Uniform recording of data and reliable sharing of it between different functions along the extended process enhances productivity, process agility, and innovation.

About the authors:

Max Kelleher is Chief Operating Officer at Generis and formerly 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.

max.kelleher@generiscorp.com https://www.generiscorp.com/

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.

remunnik@deloitte.es https://www2.deloitte.com/nl/nl/pages/life-sciences-en-gezondheidszorg/topics/iperion.html