Digital Technologies Improve Outsourcing Oversight and Information Exchange
Timm Pauli
Jim Nichols

igital innovation is playing an increasingly important role in the regulatory process. As such, it should be an integral part of the outsourcing relationship. Digital technologies are increasingly being integrated into many regulated processes in the pharmaceutical industry. Technology solutions such as artificial intelligence, automation, and natural language processing can now support the pharmaceutical compliance journey.

Within pharmacovigilance, for example, automation and natural language processing (NLP) methods are being applied to safety reporting, literature screening, and case processing. Also, within the regulatory domain, there is now more and more automation and AI-driven submission support, particularly for managing maintenance and lifecycle activities.

As an example, AI is being deployed to accurately classify documents within the trial master file (TMF) and, in so doing, significantly reduces errors. AI does this by looking at unstructured text in a document and making sense out of that by looking for a pattern of phrases or words to give the text structure.

Digital Benefits in an Outsourcing Relationship

Digital technologies are not only playing a key internal role within pharmaceutical companies, but also in how they interact with partners. When working with regulatory outsourcing partners, for example, digital technologies are proving to be invaluable tools for overseeing compliance requirements of marketed products in an efficient, cost-effective manner.

Digital tools, such as AI, provide certainty that a company’s data is not just being handled in separated database systems or individual files, but rather that there is a fit-for-purpose system infused with innovative technology. Digital tools also help to speed up processes, which is particularly important because submissions are driven by clearly defined timelines, either explicitly mandated by health authorities, or based on business or regulatory needs.

With the support of digital solutions, regulatory and other scientific teams can focus on the strategy and the scientific content instead of operational and administrative tasks. This is already happening with the use of AI to handle TMF documents during the filing process, which allows clinical teams to turn their expertise to the data and findings rather than spending time on file processing and formatting.

Moreover, use of such technologies has the potential to help build the bridge between the pharmaceutical client, their vendor, and the health authorities. That’s because advanced technology integration, using a continuous bidirectional data feed, enables a more natural exchange of information between systems where work generated by an outsourcing partner is fed back into a client company’s systems, as well as seamlessly shared with regulators. This type of bidirectional exchange is currently being used, for example, in connecting client content management systems with regulatory processing and workflow systems at the vendor. While the technology still has some way to go, it will give companies greater oversight of the submission process. Beyond the client/partner relationship, Accumulus Synergy is one organization leading the way with regards to interactions with the health authorities with the development of a communication and collaboration platform for life-sciences regulatory ecosystems to enable advanced information and data exchange.

Additionally, one of the latest developments is the use of natural language generation (NLG) to streamline the process of information retrieval and exchange. While nothing is in production, early forays into ChatGPT technology suggest that this technology has the potential to become integrated into the value chain.

It’s likely that complex and time-consuming activities, such as publishing and submission activities, will be handled in the future through automation and NG capabilities, enhancing engagement with the health authorities while enabling full visibility throughout the submission process.

Another benefit to the outsourcing relationship is quick access to regulatory intelligence and subject matter expertise. It’s important to recognize, however, that AI cannot be a complete means to intelligence gathering. While it can screen websites, it doesn’t have full knowledge of on-the-ground regulatory intelligence or what those insights mean in the context of a company’s submission or maintenance of a product on global markets and still requires human oversight and accuracy checks. But it is a means to an end for sharing human intelligence.

Through AI, expert knowledge from within different parts of an outsourcing company can be shared to support the client company’s global compliance strategy. The regulatory intelligence generated by AI and other tools also has the potential to provide insights into any issues with a marketed product by picking up patterns of problems that can then be quickly addressed.

Starting the Digital Journey

An important starting point is a cloud-based regulatory information management system that both the pharmaceutical company and vendor can access, exchanging information through a single source of truth. Already, the Accumulus “information superhighway” is enabling a single hub to support processes, data sets, and submissions.

Technology innovation aside, this natural exchange of information is facilitated by the growing body of technology standards that are emerging, such as the ISO standards that support Identification of Medicinal Products (IDMP).

While digital technologies are an enabler, transferring that information into knowledge that can be used to address an issue or improve outcomes still requires human expertise. Technology helps with highly manual and repetitive operational tasks, but it cannot provide creative solutions to manage a submission filing. It does not have that relationship with the local health authorities which is integral to successful regulatory submissions. It must, therefore, be used as a means to an end alongside human expertise through which human experts consider what might best be referred to as AI’s suggestions, which are supported by AI’s confidence in those suggestions.

As an example, while AI and automation help to accurately classify documents in the TMF, ensuring they are inspectable, these technologies can’t analyze the TMF to determine how complete it is or whether it is inspection ready. That requires the expertise of human intelligence.

What automation and AI can do is eliminate certain tasks and activities while allowing humans to focus on value-added activities in their respective functions.

Outsourcing is well-established across the pharmaceutical life cycle, and, increasingly, the partnership between the outsourcer and the sponsor company is key to successful management of different processes. Tools that assist those activities, including AI and other digital technologies, are important ingredients for a successful, long-term partnership.