Accelerate Regulatory Submissions

Automation of Clinical Study Reports (CSRs)

Narrativa Knowledge Graph® and Generative AI automate the generation of clinical study reports through data extraction and augmentation.

Solution trusted by

Up to a 6 week

Reduction in authoring time

50%

Reduction in reviews required

30 seconds

To generate the first draft

Clinical Study Reports Automation

Benefits of automated generation of CSRs

  • Streamlines processes and reduction in authoring times for 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

Technology used for CSR Automation

  • Knowledge graph
  • Data clustering
  • Entity extractions
  • Generative AI
  • Natural Language Processing

Automation of Clinical Study Reports Using AI to Accelerate Regulatory Submissions

Narrativa’s Answer to Regulatory Affairs Automation

Narrativa uses Generative AI to transform clinical trial data into CSRs. Generative AI has many applications and can be used for information extraction, answering questions, automatic translation, speech recognition or the generation of natural language. Generative AI should play a big role in the design of clinical trials and the management of reports.

Narrativa Knowledge Graph® combines several characteristics of data management paradigms, such as databases where entity descriptions are interlinked to one another and knowledge bases bearing formal semantics, which can be used to interpret data and infer new facts. Together Narrativa Knowledge Graph® and deep learning algorithms can process huge amounts of data to extract and edit valuable information while interpreting contextual information.

Narrativa’s CSR Automation solution takes into account statistical tests to reject the null hypothesis, confidence interval calculations, risk measurements (relative risk, relative risk ratios), and frequentist approaches, among other data augmentation techniques.

Automation of Clinical Report Writing

The automation of clinical study reports helps pharma companies to create more efficient processes and scale down costs. At the same time, they can better adhere to guidelines and reduce the number of mistakes and, as a result, also the number of reviews. For example, the automation of TLFs and patient safety narratives has proven to be of significant value to our partners in terms of reducing the time, effort, and cost needed by their medical writing teams to create CSRs.

More Features: Variability and Rich Language

Narativa’s CSR Automation Solution is specifically engineered to create quality content in a simple and effortless way. We require a corpus to train our system and adapt it to the appropriate or desired style so that; the final result will have variability and rich language if needed.

We use different deep learning algorithms to extract all the valuable information and ingest large amounts of medical trial data to generate the text. To achieve this in a more accurate way, we extract topics, synonyms, and similar sentences. The goal is to mimic the writing style used in the corpus.

In addition, companies maintain full control of the output. If the final result does not meet the expectations, text adjustments can be quickly made as the process is reiterated.

It is part of Narrativa’s mission to use technology for good, and transforming medical trial data into documentation is certainly a way that artificial intelligence can be democratized for the benefit of humanity.

CSR Generative AI Automation

The availability of data has completely changed the traditional pharmaceutical industry with the most significant impact being in drug discovery and clinical trials. However, the biggest challenge is to put this data to use. Pharmaceutical companies have always relied on empirical data in order to identify patterns, test theories, and understand the efficacy of treatments. It is time to trust artificial intelligence (AI) to share this knowledge with the world.

Regulatory Compliance Challenges in the Pharmaceutical Industry

Regulatory compliance is a key aspect of the clinical trial process. Clinical study reports are necessary, yet tedious to create. Medical writers spend large amounts of time creating CSRs, a time-consuming undertaking that could be better spent on higher-value tasks. The automation of CSRs helps pharma companies create more efficient processes and scale down costs.

Book a demo to learn more about how Narrativa’s Generative AI Automation Platform can transform your business through Clinical Study Reporting Automation.