EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams.
How does use of technology help?
AI-driven tools and automations enhance productivity, ensure consistency, and simplify the complex regulatory processes, allowing professionals to focus on analytical work instead of repetitive tasks.
Celegence interviewed medical writers and asked them about practical advantages of such technologies. Here is what they shared about their experience using the CAPTIS® medical writing platform:
How does a medical writing platform improve your day-to-day as a medical writer?
“Workflow is significantly improved by centralizing all reference documents, literature search results, and automated reports in one place. It also means data is easily traceable. Its customized templates save time and streamline periodic updates, helping manage complex regulatory requirements more efficiently.
“One of the standout features is its ability to configure style templates, ensuring that all content, tables, figures, headers, and footers are automatically formatted and consistent when exported to Word. Medical writers can rely on CAPTIS® for the mechanical aspects of writing, freeing them to focus on the analytical process.”
How does it help maintain consistency in information throughout various documents such as the CER, SSCP, etc.?
“Features such as the user-friendly interface and data dictionary ensure consistency in critical data and text, while the ability to leave comments and feedback across all modules helps maintain accuracy in documents.”
How can the device industry keep up with the resource challenges posed by EU MDR & IVDR?
“Increased documentation requirements under the EU MDR & IVDR are putting a strain on our industry’s expert resources. To prevent burnout and make better use of our skilled teams, investing in technological solutions is crucial, as it alleviates pressure through automation and AI. With the ability to modify and augment archived search strings, results, and screenings, document maintenance is streamlined and highly efficient.”
How does AI save up to 60% of time on literature search reviews?
“By linking directly to multiple databases and allowing uploads from others, literature reviews are far more efficient and accurate than a manual process. The AI-enabled literature module, known as CAPTIS® Copilot, automatically extracts and summarizes relevant information from research articles in seconds. This significantly reduces research workload and helps writers consistently meet deadlines.
“Among other things, it’s designed with input from medical writers. The platform addresses specific pain points like automatic generation of abbreviations, PRISMA flow charts, and automatic contents table updates.”
How do you now perform regulatory audits?
“CAPTIS® provides a single source of truth, systematically collating and analyzing data to minimize non-conformances and streamline the certification process. With the AI feature writers have confidence that they can quickly find the information they need, supporting data analysis, and enhancing the quality of their documents.”
How does the citation manager tool work?
“The in-house citation manager automatically cites and references articles within documents, eliminating the need for a separate tool. Writers can easily check article details, open them on CAPTIS®, or download them, saving significant effort and allowing them to focus on the comprehensive scientific information required by the regulatory bodies.”
How do you review documents and collaborate?
“By enabling collaboration with other authors and reviewers, the whole process is more productive. Other features, such as the data dictionary, automated reports, and content linking, enhance the review process and ensure that content is accurate.”
Watch the full interview here
Want to explore how CAPTIS® can streamline your workflow and enhance your productivity? Visit the Celegence website to arrange a consultation or a demo.
