Clinical study reports (CSRs) are long, complex documents that communicate detailed information about the conduct of a clinical study and its results. CSRs are created as part of the submission package sent to health authorities, like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Given that these documents must comply with strict guidelines and require an inordinate amount of time to produce, how can we speed up and simplify the process? Enter: Narrativa.

The problems: Writing a CSR is a time-consuming process!

Medical writers are professionals with a scientific background who collaborate with other stakeholders to author CSRs. Depending on the complexity of the clinical study, medical writers report that they need more than 200 days from CSR drafting to delivery. In addition to trial complexity, they mentioned reasons like version review cycle timelines, number of study subjects, and complexity of the therapeutic areas as factors contributing to the equation. This doesn’t even take into account the amount of time spent in preparing, validating, and modifying Tables, Lists, and Figures (TLFs).

TLFs represent clinical study results. Their creation requires collaboration between multiple stakeholders, including statistical programmers, biostatisticians, and others. Creating TLFs is the first step in a time-consuming and laborious methodology. After their creation, they need to be validated, and these steps are iterated if any modifications are made subsequently. The procedure is linear; without TLFs, medical writers cannot complete their job of compiling and authoring the CSR. Therefore, delays experienced in creating TLFs will likely cause additional delays in authoring CSRs.   

Patient narratives are another part of the CSR that takes a lot of time to prepare. The larger the trial, the higher the number of expected narratives there will be to create. In addition, factors like therapeutic area complexity also play a role. For example, the amount of narratives and effort needed to author them would be expected to be significant in a phase III oncology trial. Therefore, automating such a process could greatly expedite the process of narrative writing.

Speed up CSR reporting with Narrativa’s AI-powered tools

The solutions: Use Narrativa to significantly reduce costs and timelines

Yes! Narrativa offers multiple solutions that address major bottleneck processes that slow CSR delivery. The first solution Narrativa offers is the automation of patient narratives. Narrativa’s solutions have been proven to cut the time needed to create patient narratives from weeks in some cases, to mere minutes. What’s more, our solution highlights inconsistencies, if encountered, so that the validity of the written narratives can be confirmed. Clients utilizing our patient narrative automation tool have seen substantial time and financial savings.

The second solution Narrativa offers to help deliver CSRs faster goes upstream to address a major root cause of delay: TLF creation. Narrativa creates  TLFs that our clients can have in hand within minutes and after just a few clicks.

When combined together, these solutions help decrease the aforementioned CSR timelines by several months. This means that life-saving therapies and treatments will reach patients much faster—which translates into many outcomes like improved quality of life, reduced death rates, and many other positive developments. Another time-saving solution that Narrativa offers is the anonymization and redaction tool. This solution can scan documents made of thousands of pages within a few minutes to anonymize and redact privacy-compromising information. 

It is important to note that these are not the only solutions that Narrativa offers. This is because our clients always approach us with requests to automate sections or parts of the Electronic Common Technical Document (eCTD) that they might deem as a cause of other delays. Currently, Narrativa is also working on multiple other solutions based on our research and client demand to improve the process of eCTD automation.

Regardless of therapeutic area, pharmaceutical and biotech companies spend time and money bringing treatments that improve patients’ lives. We are here to help you introduce them to the market faster!