4 benefits of automating Clinical Study Reports (CSRs)

To carry out a clinical trial requires a lot of effort, money and time. And putting the collected data into a document is a necessary but tedious process that significantly delays drug approval. Using artificial intelligence is the solution to speed up the process. Here are 4 benefits of automating Clinical Study Reports (CSRs).

Clinical study reports are necessary, yet time-consuming

For a medicine like Ibuprofen to reach our hands, an arduous process is necessary first, which will be reflected in a Clinical Study Report (CSR). It is a document created using multiple files, like Tables, Lists, and Figures (TLFs), and provides very detailed and precise information about an investigation or experiment. The information in this document is crucial as it addresses efficacy and safety matters.

In addition, the Clinical Study Reports (CSR) have to be presented and approved by two regulatory entities:

• European Medicines Agency (EMA)
• Food and Drug Administration (FDA) in the United States

These entities require the studies to comply with certain standards in order to be present to them. Preparing the CSRs takes time and automation can help speed up the process.

What is automation?

Content automation is the use of technology to create content of any kind, be it trend reporting, an article or Clinical Study Reports (CSRs). Artificial intelligence is a great ally to content automation, specifically the generation of natural language.

Natural language generation is a subfield of AI. It is capable of processing large amounts of data and then sharing the information using human-sounding language. That is, technology can write a report just as a person would. Incredible, right?

4 benefits of automating Clinical Study Reports (CSRs)

Taking into account that only 10 percent of all drugs started in human clinical trials become approved drugs, there is no time to waste on documents.

After you have seen how difficult it is to carry out these studies, here are some benefits of automating these documents.

1. Save time and money

If we automate the Clinical Study Reports (CSRs), pharmaceutical companies will not have to spend money on extra resources. Here are two pieces of information that will surely interest you:

• 65% reduction in time spent on documentation generation
• 40% expected cost reduction on medical writing

And what does this mean? Faster approvals.

2. Error-free processes

Pharmaceutical companies want to make sure they have an error-free process. If we have a person manually entering a very large number of data, it is likely that they will make an error.

Automation achieves streamline processes and reduction in authoring times for increased operational efficiencies. Thus, pharmaceutical companies can better adhere to guidelines and reduce the number of mistakes and, as a result, also the number of reviews.

3. Improvement in study quality thanks to AI

With the help of artificial intelligence we guarantee a higher quality of the document. How?

Natural language processing has many applications and can be used for information extraction, answering questions, automatic translation, speech recognition or the generation of natural language. NLG, along with machine learning, could 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 the data and infer new facts.

Use of Narrative Knowledge Graph® and deep learning algorithms can process huge amounts of data to extract and edit valuable information to interpret contextual information.

4. Differentiation point

Technology can help differentiate you from the competition and achieve greater effectiveness in the process of creating Clinical Study Reports (CSRs).

Why automate your CSRs with Narrativa?

Narrativa can automate the generation of clinical study reports through data extraction and augmentation. Narrativa clients benefit from the following:

• Up to a 6 week reduction in authoring time
• 50% reduction in reviews required
• 30 seconds to generate the first drafts. Our technology enables an efficient process.

Our software is specifically engineered for creating quality content in a simple and effortless way. Naturally, we have different ways of approaching the situation depending on the specifics required.

This is the technology we use for CSR automation:

• Knowledge graph
• Data clustering
• Entity extractions
• Natural Language Processing
• Natural Language Generation

About Narrativa

Narrativa is an internationally recognized content services company that uses its proprietary artificial intelligence and machine learning platforms to build and deploy digital content solutions for enterprises. Its technology suite, consisting of data extraction, data analysis, natural language processing (NLP) and natural language generation (NLG) tools, all seamlessly work together to power a lineup of smart content creation, automated business intelligence reporting and process optimization products for a variety of industries.