Streamline the Authoring of eCTD Sections with Narrativa Generative AI

The eCTD is a highly standardized submission format used by regulatory authorities. Creating its components comes with its own set of challenges, but automating sections of the eCTD is possible today with the help of Narrativa Generative AI! With Narrativa:

• Automatically populate sections and subsections of the eCTD
• Integrate and reformat existing approved content for reuse in new submissions, all while ensuring regulatory consistency and compliance
• Identify and redact any portion of reused text that no longer comply with the latest regulatory standards
• Dynamically generate, cross-reference, and track changes between versions to ensure quality and a seamless review process
• Unify formatting, style, and table structures across submissions for improved efficiency
• Spend your valuable time and budget where it counts

Background about the eCTD

The electronic Common Technical Document (eCTD) is a standardized format used by pharmaceutical companies to file regulatory submissions with authorities, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. This document is mainly comprised of five sections, including administrative information, Summaries, Quality, Nonclinical Study Reports, and Clinical Study Reports (CSRs). These sections contain various information about safety, efficacy, manufacturing, requirements, label information, and other type of data needed to gain approval from the regulatory agencies.

Challenges of regulatory compliance

Authoring and compiling the sections of this highly structured submission is a challenging feat, taking several months or even more––not to mention the quantity and diverse backgrounds of the stakeholders needed to create the eCTD and its sections. Additionally, this can be complicated by other factors, like the potential errors and deviations that could be completed during authoring and compiling, leading to further setbacks in review timelines and delaying the possibility of delivering life-saving therapies to patients.

In addition to the above, there are other ongoing challenges that constantly evolve, like specifications and regional requirements. Variations between different health authorities, such as the FDA and EMA, combined with implementing minor changes as directed by stakeholders in different sections of the eCTD, can make it difficult to ensure compliance and correctness without investing significant time and human capital. Moreover, recycling content or approved text across several submissions that actually require contextual nuance, can signal compliance and inconsistency issues.

Be Compliant and Remain Compliant with Narrativa

Narrativa overcomes these challenges and more with its generative AI and automation technologies. Pharmaceutical and biotechnology companies can now ensure that the authoring and filing of eCTDs are not only compliant, but also require significantly less time and expenditure. With regard to time alone, the CSR authoring timeline can be reduced from months to hours or even days. Automating the creation of Tables, Listings, and Figures (TLFs) can also be completed with the press of a few clicks as well.

With Narrativa, you can:

• Expedite the process of populating the eCTD section
• Finish months’ worth of work in just a few hours with a few clicks
• Guarantee privacy as your data does not leave your cloud
• Create initial drafts of eCTD sections and subsections within minutes
• Ensure consistency, reliability, quality, and correctness of the outcomes
• Remain compliant with requirements set forth by regulatory authorities, such as the FDA and EMA
• Use fully automated solutions that require no coding experience
• Support your medical writers, statistical programmers, biostatisticians, and other professionals involved in regulatory documentation, review, and submission

At Narrativa, we use the latest generative AI and automation technologies to help you save time, money, and effort all while supporting your team by providing the tools to get from A to Z faster and more accurately. Have more time to innovate. Have more time for the critical processes that require human creativity. Improve the quality and consistency of your eCTDs today with Narrativa!