Generative AI Tools for Regulatory Writing

Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand scientific concepts and the latest regulations and guidelines to produce compliant regulatory documents. As a result, writing the documents required for a drug program can be time-consuming and prone to delays. 

Over the past two decades, regulatory writing practices have largely remained stagnant. This is partly due to the need for more standardization in the field and the high demand for accuracy and precision. Novel generative AI technologies can help increase the efficiency of writing regulatory documents for drug products. 

The Importance of Regulatory Writing in Drug Development 

Regulatory writers translate complex scientific information into clear and concise language targeting a specific audience. This includes regulatory agencies, healthcare professionals, and patients. Common regulatory documents include: 

• Clinical Trial Protocols 
• Investigator Brochures 
• Clinical Study Reports (CSRs) 
• Patient Narratives 

The Composition of Regulatory Content 

Not all regulatory content is created equal. The regulatory content comprises three distinct categories: 

1. Content referencing: Referencing previously produced text, data, tables, or images in new content. This can save time and effort, allowing regulatory writers to build on existing materials. 

2. Content reuse: Involves repurposing previously written content for new purposes. Reusing content helps drive efficiency while allowing writers to tailor the message and its scope to the specific goal.   

3. De novo content: Refers to creating new content from scratch. Developing de novo content can be more challenging as it requires regulatory writers to synthesize information and formulate conclusions.  

Two primary factors determine the makeup of content across these categories: 

• Writing standards: An organization’s writing standards will influence how they reference, reuse, or de novo create content. 
• Document type: The document type will also affect the blend of methods used in content creation. For example, clinical study reports typically rely on referencing and reuse. By contrast, Lay Summaries will lean towards de novo content. 

Long Cycle Times and Their Causes 

To streamline drug development, there is a push to reduce “cycle times” in regulatory writing. Cycle time is the time needed to create a regulatory document from start to finish. It includes all the steps involved, such as drafting, reviewing, formatting, and finalizing the document. 

Despite the best efforts of regulatory writers and organizations, extended writing times are still common in regulatory writing. This is due to several factors, including: 

• The intricate nature of the content can require a significant amount of research and writing time. 
• The need for high accuracy, as even small errors can invoke serious consequences from regulatory authorities. 
• The need for comprehensive review and approval cycles can involve multiple stakeholders. 

These factors can lead to documents taking significantly longer to develop than initially anticipated. For example, a CSR may take a regulatory writing team approximately 120 hours (five days) of work over four weeks. However, a fully reviewed and approved CSR can take an average of 83 days to complete from database lock. 

The timeframe for completing a CSR depends on team size, in-house operations, and the available tools and resources. 

How to Expedite Creating Regulatory Documents 

Here are some of the most impactful ways that generative AI technology can help regulatory writers expedite creation of regulatory documents:  

• Data Integration: Allows populating data-heavy reports pre- and post-database lock. This ensures that validated data remains intact in the writing process while eliminating manual intervention. 
• Using Automated eTemplates: These tools can streamline the writing process by providing a framework and auto-fill elements. This maximizes traceability, saves time, and ensures that teams produce industry-compliant reports.  
• Reusing content: Reusing previously written content can save time and effort. This can also reduce the burden of quality reviews required. However, ensuring the repurposed content is still relevant and accurate is crucial. 

There is no one-size-fits-all approach; each organization may use one or several methods. 

What is the best software for regulatory writing? 

CoAuthor is an integrated and automated regulatory writing software that uses generative AI technology to streamline document production. CoAuthor allows regulatory writers to: 

• Use predefined templates and metadata to create consistent and compliant documents with less manual effort. 
• Import and refresh analysis datasets, tables, listings, and figures from various sources and formats, ensuring data accuracy and currency. 
• Integrate with Pinnacle 21 Enterprise validation tools and Certara.AI deep learning engine to enhance data quality and generate insights. 
• Collaborate and communicate with multiple stakeholders across teams and organizations, facilitating review and approval processes. 

CoAuthor enables regulatory writers to focus on the key analysis, relevant messaging, and regulatory requirements of their documents. At the same time, it reduces the time and cost of document creation. CoAuthor is a comprehensive and innovative solution that simplifies and accelerates the regulatory writing process. 

Conclusion 

Medical communications are a time-consuming but crucial component in developing new drugs. Ensuring accuracy and adherence to regulatory benchmarks can prolong regulatory writing cycle times. However, implementing appropriate strategies can empower regulatory writers to accelerate the creation of regulatory documents, thereby streamlining the drug development process. 

To learn more about using generative AI to automate repetitive writing tasks and leverage structured content, watch our informative webinar: 

References 

1. Certara. Applying Technology to Expedite Regulatory Writing.  

2. Barton B, Davidson S. Good practice in medical writing. Biochem Soc Trans. 2011 Oct 1;39(5):1341–1343. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149406/