Today, discussions revolve around the impact of artificial intelligence (AI) across various industries. We have witnessed a sweeping wave of changes after the release of Generative Pre-trained Transformer-3 (GPT-3) as well as other subsequent releases.

Many industries and businesses were quick to harness the potential and ride the wave of AI by adopting and implementing this suite of technologies to fill in the gaps and overcome business barriers. The healthcare industry is no different. However, there is one area where the adoption of AI still lags despite its significant potential—the field of regulatory submissions. Many reasons fuel this delay, such as concerns from medical writers, sponsors, and other individuals involved in the process of conducting, documenting, and the filing of clinical research documents.

Let’s journey together to understand how generative AI technologies can support the industry.

The regulatory automation trifecta that’s driving positive results

As we mentioned earlier, there are several reasons for the lag in adopting generative AI technologies in the regulatory submission industry. Other factors, though, involve the pace at which pharmaceutical and biotech companies implement AI and related software because of the convoluted processes and procedures associated with introducing and adopting new technologies.

However, early adopters of the technology have reported positive effects on the overall performance of medical writing teams and other stakeholders involved in conducting and documenting clinical research—not to mention the organization as a whole.

When using Narrativa’s tools to create and author regulatory documents, like clinical study reports (CSRs) and their associated elements, such as patient narratives, the reported outcomes were:  

• Improved Efficiency: Stakeholders who used Narrativa’s tools reported a significant improvement in efficiency by virtue of having an automated solution for regulatory documentation. This is reflected through the reduction of time needed to complete routine tasks from hundreds of hours to a few minutes.
• Enhanced Accuracy: Narrativa’s suite of solutions helped stakeholders involved in clinical research, including medical writers, improve the accuracy of the outcomes submitted to regulatory authorities. This is because the solutions skim through various databases (which could involve numerous data points and connections belonging to many patients) and highlight problems related to the data. This way, medical writers are empowered to create more accurate outcomes.
• Consistency: Organizations that have adopted Narrativa’s technologies noticed that once a solution was optimized to meet their specifications, consistent outcomes (in terms of format, style, and other elements) were assured. This means that many days that are usually spent on compliance with internal policies and regulatory requirements may be saved.

Narrativa’s solutions combine all these elements into one, giving you the power to achieve more in significantly less time.

Does Narrativa offer other solutions that could speed up regulatory submissions?

The answer is a big YES! In addition to the above, our solutions also automate Tables, Listings, and Figures (TLFs), which are critical elements needed to create CSRs. The TLF solution does not require any coding experience; you only have to load the data, select the parameters you want to include and watch the magic happen in no time. Moreover, we offer an anonymization and redaction solution that saves you a significant amount of time by delivering results within a few minutes!

Our clients consistently approach us with requests to create new solutions that involve regulatory documentation and submission processes across the whole spectrum of clinical research. Their requests are about using AI-driven solutions to improve the efficiency of their organizations and direct the human capital toward more tasks that require human input rather than routine, repetitive tasks. Tell us what YOU need though, and we will work to make it a reality!