Narrativa’s solutions pave the way toward more accurate clinical research databases

Clinical research databases are made up of numerous data points based on information collected from many patients while a study is conducted. The complexity of these databases increases when the number of study participants increases. Having errors in these databases negatively affects investigators, patients, pharmaceutical and biotechnology companies, and more. Let’s find out how!

Understanding the impact of errors in clinical research databases

Before getting to their impact, we need to understand the importance of having accurate databases. The accuracy of clinical research databases is essential for producing reliable outcomes, like Tables, Listings, and Figures (TLFs) as well as documents like clinical study reports (CSRs) and their component pieces, such as patient narratives, among others. This is because these outcomes rely on properly connecting various data points across databases to produce them. So, how could errors in these databases affect companies and other stakeholders involved in the process?

Minor errors in these databases could have a cumulative negative influence that leads to ill-informed conclusions by investigators. In turn, this could potentially have negative consequences on the lives of numerous patients involved in these studies in addition to the ones who are meant to use the treatment after approval. Moreover, it could set pharmaceutical and biotech companies back months or even years behind their goals due to failing to meet regulatory agencies’ documentation and submission standards. In cases where there are grave errors, submissions could be rejected.

This demonstrates how errors in clinical research databases could trigger a chain reaction that ends with significant time and monetary losses for companies. So, what does research in this area reveal?  

Results from the available scientific literature mention errors in clinical research databases reaching high proportions of up to 27%, highlighting the seriousness of this issue. The literature attributes the majority of these errors to incorrect and missing information. Analysis also reveals that error detection in these databases is underestimated, and the constraints set to prevent such errors only modestly succeed in this area. So, is there another way to mitigate the effects of these errors and highlight them for medical writers, statistical programmers, and other stakeholders involved in clinical research? The answer is one word: Narrativa.

Narrativa’s solutions detect mismatches and errors in databases!

Narrativa offers many solutions that help automate processes, like anonymization and redaction and the creation of TLFs, patient narratives, and much more. We provide significant value in terms of assisting pharmaceutical and biotechnology companies with saving time and money.

The capacity to highlight inconsistencies in databases is yet another unique feature that Narrativa offers. In this way, medical writers and other stakeholders involved in clinical research are able to spot these errors and take appropriate measures, resulting in a greater level of accuracy when communicating the research outcomes—reducing the chances of rejection from regulatory authorities due to documentation and reporting mistakes! Moreover, understanding the factors driving these errors means that companies can develop plans to overcome them in subsequent studies.

Collectively, our suite of Generative Artificial Intelligence solutions overcomes multiple gaps that could prevent Life Sciences companies from getting their life-saving treatments to those who need them the most.

About Narrativa

Narrativa is an internationally recognized generative AI content company that believes people and artificial intelligence are better together. Through its proprietary content automation platform, teams of all types and sizes are empowered to build and deploy smart composition, business intelligence reporting, and process optimization content solutions for internal and external audiences alike. 

Its tech stack, consisting of data extraction, data analysis, natural language processing (NLP), and natural language generation (NLG) tools, all seamlessly work together to produce content quickly and at scale. In this way, Narrativa supports the growth of businesses across a variety of industries, while also saving them both time and money. Accelerate the potential with Narrativa.

Contact us to learn more about our solutions!