Reducing Redundancy: How Structured Content and AI Reduce Rework in Medical Writing

Medical writers need to ensure that key messages are presented consistently and accurately across clinical and regulatory documents. When multiple writers are working on different documents within the same development program, they run the risk of duplicating effort and introducing inconsistencies by rewriting the same information in different ways. This lowers the quality of the documents and may result in timeline delays.  

Artificial intelligence (AI)-assisted structured content authoring is a new strategy that can help writers avoid these potential pitfalls and streamline the authoring process. Clinical research documents

should be structured based on regulatory guidelines, company standards and conventions, and principles of effective scientific communication. AI tools can be used to insert pre-approved, standardized content directly into documents to help teams improve efficiency and facilitate content reusability across documents. 

How Does AI-assisted Structured Content Authoring Work? 

Unstructured content refers to text, tables, and figures that medical writers can create and organize in any configuration throughout the document. Structured content, however, is standardized text that is designed to be reused across multiple documents within the company. This content is written, reviewed, and approved by subject matter experts and stored in a central repository. Instead of rewriting the same text, writers can simply pull the text from the repository with the knowledge that it is accurate and approved by the team. This eliminates the need for writers to perform repeated consistency checks between documents. For example, multiple clinical study protocols using the same investigational drug may require the same information to be included in the background sections. If pre-written structured content is available in a central location, the protocol writers don’t have to worry about introducing inconsistencies by manually copy and pasting content from one document to another. 

AI-based structured content management tools can be leveraged to maintain a content library and insert the content in the correct place within each document. Each piece of structured content is referred to as a component. Each component addresses a particular aspect of the study such as the patient population or study intervention administration. Instructions can be added to the document template or configuration file that direct the AI tool to the appropriate place to insert each component. Once this system is established, the necessary text can be inserted with the click of a button!  

How Does This Reduce Rework and Improve Document Quality? 

Medical writers are under intense pressure to meet deadlines, and it is critical to identify new ways to improve efficiency in the clinical documentation process. Structured content libraries are searchable, which saves authors the effort of manually searching through documents for the text they’re looking for. Reusing standard content helps speed up the authoring process and frees up the author’s time for more complex tasks such as interpreting data and leading discussions with stakeholders.  

Structured content has already been reviewed and approved by subject matter experts, so it does not need to be reviewed again during management or quality control reviews. Content components can be locked to prevent other team members from making edits. This allows for a more targeted review process and reduces the time to document finalization even further. Overall, automated structured content authoring reduces the need for manual manipulation of reused content, ensuring accuracy, clarity, and consistency across documents

Conclusion 

Busy medical writers don’t need to spend time reinventing the wheel. Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them. 

Want to learn more? Connect with us to learn how Synterex is leveraging AI to streamline the clinical documentation process.