Transforming Clinical Trial Regulatory Reporting with Next-Generation AI Technology


Regulatory submissions involve interactions between many different departments to provide documents and files for medical writers to produce outcomes, like Clinical Study Reports (CSRs), Patient Safety Narratives, Tables, Listings and Figures (TLFs) and other files. This process requires medical writers to review thousands of inputs to make a final report, increasing the likelihood of errors and problems while taking hundreds, if not thousands, of hours and manpower to deliver a final submission to the regulators. The best practice is to avoid unnecessary risk with regard to processes that take so much time and money to complete. Artificial Intelligence (AI), Natural Language Processing (NLP) and Natural Language Generation (NLG) technologies have the potential to reduce cost, time and risk by automating the authoring process so that medical writers can focus on more critical tasks. Instead of drowning in data analysis, highly skilled medical writers who utilize AI to assist with creating laborious “first drafts” of regulatory documents may use their time and talents to reinforce QA (quality assurance) and QC (quality control).

As one of the fastest growing artificial intelligence companies, Narrativa is internationally recognized as a leader in developing automated content for various industries, including media, gaming, marketing and finance. Narrativa’s proprietary technology suite, consisting of data extraction, data analysis, NLP and NLG tools, all work together seamlessly to power a lineup of smart content creation for these industries—including Life Sciences. In fact, having had great success over the past eight years, Narrativa is now the leading AI company focused on supporting Life Sciences with its AI Medical Writing Assistant. It provides the most advanced and innovative automation solutions for clinical trial regulatory documentation—everything from Patient Safety Narratives to TLFs. The company is also rapidly applying its robust proprietary AI automation tools to every area of regulatory reporting; most importantly assisting with tedious tasks that can be fast-tracked. Consequently, drug trials see a 40% reduction in cost and a 65% reduction in authoring time on average. This also of course gets drugs into pharmacies faster and helps those who need it the most.

Automating Patient Safety Narratives

Patient Safety Narratives are a key part of Clinical Study Reports (CSRs). Narrativa enables a more efficient authoring process and automates the repetitive elements within patient safety narratives to save valuable time while also providing:

  • Up to a six week reduction in creation time
  • A 50% reduction in reviews required
  • A first draft within 30 seconds for medical writers to review

Narrativa’s AI Medical Writing Assistant also produces:

  • Pre-formatted and editable narratives (with the ability to modify in any way)
  • Improved consistencies in narrative generation
  • An improvement of the revision process
  • A significant reduction in reporting conflicts
  • A better quality control process through audit trails and version tracking
  • Narratives that comply with regulations
  • An acceleration of the final approval process
  • Delivery of patient safety narratives in batches

Automating Tables, Listings and Figures

Narrativa’s AI technology suite helps overcome the gaps associated with TLFs. Our solution utilizes artificial intelligence, NLG and NLP to sift through thousands of layers of inputs and data to create TLFs.

Narrativa’s solution does not only understand the data but can also reason and interpret their meaning. This could save statistical programmers and analysts days (or even months) worth of time and spares them from going through thousands of static pages. Our solution is as easy as counting one, two, three: (1) Upload your files, (2) press a few buttons to provide parameters, and (3) then your TLFs are produced.


The benefits of automating TLFs include:

  • A 50% reduction in costs
  • An 80% increase in speed
  • Generation of TLFs that are compliant with regulators in only a few minutes
  • Updating of titles and footnotes with ease
  • Reduction/elimination of bottle-neck processes, like frequent changes and quality checks when coding, creating, updating and validating TLFs
  • Acceleration of regulatory submission to health authorities
  • No coding or programming experience necessary

Automating Clinical Study Reports (CSRs)

The Narrativa Knowledge Graph® and deep learning language algorithms automate the generation of clinical study reports through data extraction and augmentation.

The benefits of automatically generated CSRs include:

  • Streamlined processes and a reduction in authoring times
  • Increased operational efficiencies
  • Better regulatory compliance and adherence to guidelines
  • Reduction in the number of reviews required
  • Significant reduction of costs and overhead
  • Faster approvals

Narrativa's AI automation services are leading the way in the digital age by leveraging expertise in clinical trial reporting, data analysis and other vital areas to empower businesses of all sizes within Life Sciences. As the industry evolves, Narrativa’s sophisticated solutions are boosting efficiencies, elevating performance, expediting drug development timelines and ultimately making a meaningful contribution to saving more lives.

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