Life sciences companies may have regulatory information management systems, but are they being used to their full potential?
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Data isn’t just something that regulators crave and want more of. It should be driving new innovation and value right across the life sciences lifecycle. Yet, even today, to get a clear picture of what’s going on at any point across R&D, safety/pharmacovigilance or global marketing, teams have to painstakingly pull together diverse information and pull it into a PowerPoint presentation. The data in it may or may not be complete, and the slide deck will be as current as when the last piece of information was cut and pasted into it. It’s hardly a dynamic or roundly insightful situation.
Companies that are still tackling this from a muddle of spreadsheets and static documents are clearly not data and analytics driven. But even large companies with decent regulatory information management systems cannot be assumed to be exploiting analytics to its full potential. Perhaps their RIM systems don’t have modern real-time reporting capabilities built in; or maybe they have overlooked these in favor of building a proprietary analytics solution - or buying into something distinct to perform that task.
Whatever the particular set-up, the chances are that companies are not running their operations, or planning, scheduling, monitoring and optimizing aspects of what they do, in a cohesive way using the latest data. And this omission or oversight is doing them a great disservice.
Knowledge is power: amalgamated analytics should be the thread tying your RIM processes together
Data collation and analysis is nothing new: it’s a practice that goes back decades – centuries, even – albeit data warehouses/data lakes and cloud-based analytics have transformed the scale and speed with which companies can capitalize on the latest insights, bringing more diversity, depth and immediacy to conclusions and their delivery.
Outside of life sciences we see rich, real-time data transforming the way retailers, financial services and healthcare are delivered, and creating new experiences for consumers/patients. But in pharmaceutical and medical devices manufacture, the ambitions for analytics remain relatively modest. Too modest.
If teams were to examine the potential of their existing IT systems more closely, they might:
- discover new options to accelerate drug discovery and development
- accelerate the delivery of vaccines to target markets
- optimize the efficiency and quality of clinical trials
- better target drugs as treatments become more personalized
- more precisely understand and predict patient behavior
- hone safety and risk management
- and improve sales and marketing performance.
The key to all of this is the ability to bring diverse data sets together from across the organization and/or supply chain swiftly and reliably, and analyze them on demand to inform current decisions and make more accurate predictions.
Leverage your existing IT investments
So often, companies invest millions in robust regulatory information management systems, only to use them to a fraction of their potential.
As they update their capabilities to deliver against new IDMP requirements or, in the case of medical device manufacturers, MDR obligations, the teams working most closely with the data should be checking for inherent analytics and reporting capabilities – including the option to visualize real-time findings in highly intuitive ways.
Beyond colorful 3D graphics, why not seek out support for virtual reality walkthroughs – the ability to manipulate data representations in different ways, to view them from another perspective. Or the ability to augment and enrich initial insights with other, overlaid findings.
Even where brands lean on contact research organizations (CROs) or other external partners to do some of the heavy lifting for them, they should be looking to retain access to and control of the data, so that they can feed it into their broader operational monitoring, analysis, forecasting and planning.
The potential benefits of visualizing data and accessing rich insights on demand should not be underestimated. All of this could help improve efficiency, reduce risk and expedite market access.
Best practice involves linking data traceability and analytical ability right along the product lifecycle -from compound to clinical trials, to market delivery and in-market regulatory maintenance and safety monitoring.
As the latest raft of data-related regulations in life sciences force changes or updates to existing system capabilities, our advice to companies is: don’t miss a trick. Use this as a chance to boost real-time data visibility and drive new insights. Your business performance will be healthier for it.
About the author
As Global Strategic Accounts Consultant at Amplexor Life Sciences, based in the UK, Ian Crone is responsible for understanding client challenges and working alongside customers to identify optimum global solutions - a role involving international travel and long-term customer engagement. His background is in chemical engineering – the subject of both his university degree at Strathclyde University in Scotland and the first 14 years of his career, at Unilever. Over the two decades since, Ian has been involved in the chemical and pharmaceutical industry, from every angle of drug development, for the biggest names in life sciences. He has been involved both from an industry and technology supply side, in roles at Oxford Instruments, BioStorage Technologies and Samarind. Before joining Amplexor, Ian spent a decade at biotech advisory firm IAC Global Consultants, helping biotech companies build bridges with large pharmaceutical and chemical companies.