5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions

Moving a drug from development, through clinical trials, to eventually the market involves many critical content pieces and challenges along the way.  

According to research commissioned by Genpact, 72% of senior executives across the life sciences industry cited regulatory affairs timelines as one of their three most important challenges. They also found that 50% of a team’s time is spent on burdensome administrative tasks. There’s no question that regulatory teams’ pain points extend beyond deadline pressures. With ever-evolving guidelines mandated by health authorities like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), clinical and regulatory teams must create, translate, and fully adhere to submission standards for complex regulatory content documents. If any step is handled incorrectly, organizations can face costly legal penalties for non-compliance and significant delays in getting market approval for life-saving medications. 

By leveraging the transformative power of generative artificial intelligence (GenAI) and machine translation workflows, organizations can mitigate risk, maintain compliance, reduce administrative timelines, and save on costs. With this in mind, let’s examine five significant use cases for GenAI and MT for the regulatory content authoring and submission process.

Automated Document Generation

In clinical trials, regulatory content submissions involve a series of documents sent by the life sciences organization to its required national health authority as evidence of compliance. Regulatory teams are required to include the following documents in their submissions: 

1. Investigational New Drug (IND) Application
2. Clinical Trial Protocol
3. Investigator’s Brochure (IB)
4. Informed Consent Form (ICF)
5. Case Report Forms (CRFs)
6. Clinical Study Reports (CSRs)
7. Patient Information Leaflets
8. Adverse Event Reports
9. Statistical Analysis Plan (SAP)
10. Quality Assurance Documents
11. Regulatory Correspondence
12. Product Information
13. Nonclinical Study Reports
14. Ethics Committee/Institutional Review Board (IRB) Approval
15. Trial Registration Information
16. Investigator Agreements
17. Insurance and Indemnity Documentation
18. Misc. documentation (including additional logistics and planning documents related to the trial)

To reduce the time and costs involved with creating any of these documents manually, GenAI can be leveraged as an automatic authoring tool to enable content reuse, dynamic templates, and efficient content development procedures. By utilizing machine translation memories, glossaries, and linguistic assets, content outputs can be tailored to a specific document’s layout, required terminology, and audience. A human subject matter expert should always be kept in the loop during the post-editing process to verify the quality and accuracy of the AI’s creations. 

Multilingual Translation and Localization 

Due to regulatory requirements, life sciences organizations need accurate translations of their regulatory content to expand their products globally. With speed and cost efficiencies, machine translation can analyze commonly used language patterns and integrate with API tools to quickly process large volumes of content. GenAI takes its strengths one step further. By translating with context, regulatory teams can automatically translate industry-specific jargon and increase localized readability across their submissions, no matter where the audience is located. This utilization can be especially optimized for patient-facing documents during a clinical trial, such as the Informed Consent Form and Patient Information Leaflets.

Data Synthesis and Summarization

By collaborating with GenAI and training it on historical datasets, teams can quickly synthesize clinical trial research and create concise, summarized reports where necessary. With provided case descriptions, GenAI can synthesize and generate essential regulatory reporting content, such as Adverse Event and Nonclinical Study reports.

Regulatory Intelligence and Compliance Monitoring

GenAI is transformative in automatically analyzing regulatory guidelines, historical content submissions, and past feedback from regulatory agencies to generate insights and recommendations for each compliance submission. By tracking and mapping trends, it can also identify gaps in the market and audit competitor data. 

Quality Control and Consistency Checks

During the final review within the regulatory content submission process, machine translation and GenAI-enabled workflows can perform automatic quality control by checking for translation consistency, accuracy, and completeness across all documents and datasets. Historically an intensive process prone to human error, this workflow can ensure all requirements are met, thereby reducing the likelihood of regulatory delays and rejections. 

Conclusion

By embracing cutting-edge and transformative GenAI and machine translation technology, regulatory teams can experience reductions in costs, administrative burden, and timelines while increasing quality and improving safety. With the team’s increased bandwidth, they can solve higher-level issues and continue to develop life-saving drugs without the risk of burnout.

TransPerfect Life Sciences has developed AI-enabled tools to help regulatory teams reduce filing timelines while avoiding critical errors and regulatory roadblocks. If you are interested in how these AI solutions can help your team navigate the complexity of global regulatory content submissions, reach out today to learn more.