Most Life Sciences organizations appreciate by now that the push to data-driven Regulatory processes, and Regulatory Information Management (RIM), has a purpose far beyond that of satisfying the way the authorities want to work. This is about transforming the processes by which companies track and manage their products from conception and development to post-marketing surveillance and maintenance – in the interests of shortening development and maintenance cycles, improving supply continuity, empowering physicians and patients, and upholding patient safety.
A recent webinar hosted with my colleague, Renato Rjavec, looked deeper into what’s involved in a holistic, end-to-end RIM capability – one in which the whole spectrum of critical operational insights are available digitally, on demand. From tracking and managing registrations and submission requirements globally, to pre-empting and mitigating issues such as shortages, to managing the cascading impact (e.g. to submissions, or labelling) when something changes to a product, its manufacture, its indications, or the associated safety advice.
It all starts with a clear line of sight
Data-driven process automations can help shore up and accelerate all of this, as long as there is access to the latest information about where products are registered and what information has been submitted and approved in the past. With embedded content management, this becomes even more efficient.
Extending insights and processes beyond the Regulatory sphere can multiply the benefits, too. Ultimately, holistic, end-to-end RIM is about transforming processes right across the product lifecycle, with a positive impact on the entire value chain, as well as connected areas like Quality and Safety management.
This is what the Amplexor Life Sciences suite is designed to facilitate, harnessing approved, reliable master data to serve as an enabler across all business processes. In other words, a complete set of high-quality data exists that can be accessed and harnessed in a range of different contexts.
In our recent webinar, we used visual demonstrations and use-case walkthroughs to demonstrate the role of rich data granularity in enabling extensive and reliable data reuse, thereby maximizing process efficiency and reducing the risk of errors.
Our solution offers different options to cater for quality and accuracy, which again we demonstrated in the webinar. Where teams feel unsure about what they have put together, they can verify the data and ask the system to execute it. Alternatively, once someone has completed a process of data definition in the system and wants to submit this for approval, the system checks it over first to save time: automatically verifying the data according to defined business rules. This saves the human approver from having to reject something outright because of errors in the data. When every loop of rework costs time and money, the ability to identify potential issues and address them ahead of time can be invaluable.
What’s next for holistic RIM & its strategic scope?
The future holds even greater potential. Here are just some of the next developments on the horizon:
Cloud by default
Already today, cloud adoption is transforming the way the Life Sciences industry can access and harness technology, and make data and content securely available to global teams and even external partners, in a highly scalable way.
Ontologies to help connect data
The concept of master data, meanwhile, enables a ‘single source of truth’ across a company, as a foundation for extended, end-to-end benefits of RIM across the enterprise. One big challenge that many companies are facing at this point, however, is how to present though the complexity of their evolving data landscape, whether this already harnesses a holistic RIM capability, or has to piece its ‘truth’ together from across a plethora of departmental systems.
‘Ontologies’ can help companies to map all of the data and its interdependencies. An ontology defines where data is stored, how it is interconnected with other information assets, the rules managing these data elements, and so on. As companies try to get to grips with their complex IT estates, we will see ontologies rise in prominence – as a practical stopgap in the mission to harmonise data.
Blockchain is coming to Life Sciences, too, with potential to significantly enhance data security and primary data integrity. Think of it as an audit trail on steroids – one that can never be altered, even by super users.
Next-gen automated content generation
Structured content management, meanwhile, will be advanced with AI algorithms, while robotic process automation will continue to offer value through the flexible automation of repetitive operations.
Advanced analytics & search
Advanced analytics will allow users to build their own reports or dashboards, on an ad hoc basis using the data elements available as part of a company’s increasingly holistic RIM capability. This could also be developed to include predictive analytics and signal detection, supporting business decisions based on the insights that are emerging.
ChatGPT and technologies like it are likely to have a bearing on the way teams work, too, if only by elevating the profile of AI and machine learning potential. Potential applications range from the auto-classification of content to data extraction to the delivery of enhanced regulatory insight; ‘elastic’, chatbot-enabled search; and advanced content generation (e.g. of summary reports, or clinical study reports), to the point that humans just need to check them over as a last stage.
Ultimately, the future of holistic, data-driven RIM should provide the regulatory user with a more comprehensive view of regulatory data and enable them to make more informed decisions based on complete and detailed insights. That’s assuming interconnection of all contributing data (ideally by design), and in due course greater and smarter automation.
The potential gains are considerable – from a faster time to market and improved competitive position, to increased patient engagement and safety.
- A recording of the webinar, Holistic RIM – Maximizing the Value of Regulated Data, is available to watch or download at https://www.amplexorlifesciences.com/holistic-rim-maximizing-the-value-of-regulated-data/
Head of Product Management & Consulting
About the author
Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
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