How to expedite your clinical trial reporting: The pivotal role of AI

A premier resource of AI for life sciences, pioneers can save up to 30% of time generating crucial reports for regulatory submission.​ 

The road to regulatory approval of a new drug is long, winding and must pass through the Clinical Study Report (CSR), a typically exhaustively detailed work explaining the design of the study, the participants, drug safety and efficacy, among other relevant information. All this and more are required by the FDA prior to the approval process. In the analog age, the documents required by the FDA for a single drug submission would fill a tractor trailer!

A team of highly specialized medical writers is tasked with producing reams of documentation for each potential new drug, which requires weeks if not months to produce.

The massive amounts of reporting, severe time pressure, and zero error for margin have always presented an opportunity for technology to help get these life-savings therapies submitted and approved faster. Just a scant few years ago, automation in this space was unheard of.

Yseop (pronounced “easy op”) has emerged as the leader in artificial intelligence (AI) solutions for medical writers and is a pioneer in Natural Language Processing (NLP) technology. Yseop’s expertise lies in data analysis, machine learning and language. Forward thinking firms in life sciences – including a majority of the top 10 pharmaceutical companies – have recently partnered with Yseop to meet the challenge.

Yseop’s Augmented Analyst platform transforms data into high-quality narratives and tables to instantly draft error-free regulatory submissions. Yseop’s cutting-edge AI technology empowers users to be faster and more accurate. By automating the sometimes grinding work of going from raw data to first draft, writers are more fulfilled and can spend time on the problems that the complexity of the human mind was seemingly made for. Now, users are set up for success and can focus on the fine-tuning of building a submission.

Yseop worked with one of the world’s top multinational pharmaceutical and healthcare company, the first to leverage Yseop’s expertise in NLG to streamline the generation of its clinical study reports and deliver submissions to the regulatory agencies faster.

Yseop collaborated with this French healthcare company and its team of medical writers to build the world’s first NLG product tailored to their work. The solution was a human-in-the-loop automation system that produced draft sections of CSR text for review. The system mines clinical data for complex, rule-based analysis.

Yseop’s Augmented Analyst is driven by a framework called “intentions”, which are libraries of reporting typologies and text structures commonly used in medical reporting. These intentions enable a multitude of potential text outputs from a single rule to incorporate the right data and configuration. This represents a significant step forward from traditional template-based systems that are static in narrative output.

Today, the French multinational pharmaceutical company can automate two crucial sections of the CSR for phase 1 and 3 clinical studies in a variety of therapeutic and vaccine use cases. This resulted in a massive reduction in writing time which allowed writers to focus on more higher-value tasks.

Yseop’s Augmented Analyst arrives at a pivotal point in clinical trial expedition - the COVID-19 pandemic has forever altered the landscape as evidenced by the speed-to-market of the initial vaccines. “Big pharma executives know that the COVID-19 vaccine was delivered to market in less than two years, an extraordinary event, requiring them to radically change their way of delivering drugs today,” said Emmanuel Walckenaer, CEO of Yseop.

“Delivering effective treatments, vaccines and testing kits at the speed of light has pushed the industry to the limit; pharma has re-evaluated its drug approval and reporting processes,” he continued. “The pandemic has caused the industry to pivot from deliberate and painstaking processes to speed and agility that developed life-saving vaccines and treatments in less than one year – a process that historically has taken up to a decade.”

Enhancing the human element

A hurdle that Yseop and its clients are overcoming is the myth that AI will replace the human medical writer. Of course, that is not the case. It is a tool that – true to its name – “augments” the writer’s performance and duties, helping the writer to meet project goals quickly and accurately, while allowing opportunities to utilize their more sophisticated skills. The Augmented Analyst performs the tedious tasks, freeing up the writer to spend more time on the critical nuances and demands of the CSR.

More specifically, Augmented Analyst automates the core, repetitive parts of clinical study reporting, utilizing advanced AI based on standard reasoning that needs to be applied to the data for every drug that goes to submission. The medical writers can then focus on the most complex elements of reporting, which require a deeper level of human thought, knowledge and experience – attributes that cannot be replicated or replaced by AI.

Automating the writing of CSRs reduces report writing times by an average of 30%. This translates into significant cost savings, enabling analysts to focus on more valuable drug discovery projects and ultimately speeding up the process of bringing potentially life-saving drugs to market. 

For example, according to Walckenaer, a representative from Eli Lilly, a recently onboarded customer, commented that despite having “zero technical background,” she configured the program herself.  While speaking at a conference, a Lilly representative told the audience that it used to take a minimum of four hours to write one adverse event narrative and with Yseop, an unlimited number can be produced in four seconds.

Pharma is embracing AI, and Walckenaer noted that in the next 12 months, Yseop’s Augmented Analyst will be used in approximately 100 clinical trials, with this number set to explode in the coming years.

Summary

It takes between 8-12 years to get drugs from inception to market. AI has begun to radically transform the life sciences industry. Yseop’s Augmented Analyst is a fully packaged tool that accelerates regulatory submissions for clinical trials. It requires zero coding and automates all or significant portions of documents, which results in faster delivery of vital drugs to market faster to help save lives and increase well-being.