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Blog: 5 New Innovations Set to Transform Regulatory Information Management

Learn how exciting new technological innovations are set to impact how regulatory information management teams work in 2024 and beyond.

A man in a lab coat works on a computer

The Rise of Artificial Intelligence in Life Sciences 

The rise of artificial intelligence (AI) is fundamentally changing how we conduct our daily lives. There has been a proliferation of AI-powered capabilities – including voice assistants and chat bots, algorithmically recommended products, services, and content, language processing applications, and much more – with even more transformative innovations right on the horizon. 

This is leading to changes across industries, which includes regulatory information management. Life sciences firms are already harmonizing their databases and processes, increasing interoperability and accessibility of regulatory data across the enterprise and the next step is taking advantage of the AI revolution, to implement solutions capable of delivering advanced AI and analytics capabilities. 

Interest levels in these innovations are high. For example, according to a recent Gens & Associates study1, 73% of top respondents in the large survey tier are interested in investing in AI/ML algorithms, while 51% of firms surveyed are currently working on a digitization strategy. 

Benefits these innovations can provide include: 

  • Empowering Knowledge Workers – Reduce mundane tasks to gain efficiencies and allow team to focus on value-adding activities. 
  • Improving Data Quality – Quickly run comparisons and checks on vast amount of data spot discrepancies and ensure consistency. 
  • Enhancing Decision-Making – Readily understand the impact of new regulations and other changes on global compliance. 
  • Accelerating Time-to-Market – Save time and effort by more efficiently processing large amounts of data, tasks, and information. 

Driving Innovation with LifeSphere Regulatory 

It is clear why life sciences firms are interested in taking advantage of these innovations – but in entering this new year, how can they best realize that value through tangible, achievable use cases?  

As we enter 2024, we are making significant investments in our LifeSphere Regulatory platform to drive industry-leading innovation and ensure life sciences firms realize the benefits of the latest advancements in AI and analytics. 

Below are 5 key transformative use cases that we believe will have the most immediate user benefits. 

Content Ingestion and Processing 

Life science firms currently spend considerable manual effort working to ingest and classify regulatory content and trigger related regulatory actions. New innovations are enabling life science firms to automate these processes, including the ingestion of health authority (HA) communications, as well as submissions in non-standard formats. 

This automation can lead to significant efficiency gains in regulatory operations and increase the quality of HA interactions. It also helps firms to build the knowledgebase of questions and responses to HA communications, as well as consistent submission archives.    

Automated Content Generation 

Firms need more efficient ways to review available data and summarize findings to ensure products remain compliant with global regulations, while instilling confidence their findings and conclusions are sound. To help with this, firms are increasingly relying on automation for content generation. 

From drafting documents such as HA responses, summary reports, DSURs or PSURs, to summarizing documents to provide quick content insight and translating documents such as national HA regulations or correspondence, automation can lead to significant authoring effort savings, allowing experts to focus on high value tasks and increasing accessibility and quality of regulatory content. 

Compilation of Regulatory Submissions 

It is often tedious and time-consuming to compile registration and variation submissions using the right documents in the right context. New innovations can streamline these efforts, including the automation of global submission management, submission compilation, and quality checks of compiled submissions. 

This automation can lead to significant efficiency gains in regulatory operations, an increase in the quality of regulatory submissions and the percentage of submissions done correctly the first time, and shorten overall time to market through faster submissions with less errors. 

Enhanced Regulatory Intelligence 

Keeping up to date with ever-changing regulatory requirements across the globe is a major undertaking. Automation can help alleviate this by enabling life science firms to collect, classify, translate, and summarize new regulations, summarize changes between regulation versions, automatically ingest new guidelines, and provide regulatory users with contextual regulatory insights during daily work. 

Together, this enables faster distribution and comprehension of regulatory changes, which leads to an increase in quality of regulatory submissions and a decrease in deficiencies and rework needed, while also shortening the overall time to market. 

Conversational Information Discovery 

Finally, life science firms need a more efficient and flexible way to extract insights from data and content, to make more informed decisions, and ensure more consistent regulatory compliance. 

Conversational UI offers a solution to this, enabling teams to extract insights from regulatory content repositories, analyze regulatory data, and get guidance based on the regulatory intelligence knowledge base. By leveraging generative AI to query repositories and databases for information, it becomes much easier for team members to get the insights they need in real-time 

Life Science Regulatory Information Management Innovations in 2024 

Ready to learn more? Check out our webinar “Life Science Regulatory Information Management Innovations in 2024” for a detailed look at how the industry is changing, our key predictions for how it will evolve in 2024, and what to keep in mind as you build your 2024 strategy. 

1: Source: Gens & Associates 2022 World Class RIM Study. 

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