Revolution in clinical evaluation: How AI boosts CER writing
AI is radically transforming CER writing, offering a solution to the challenges of bibliographic research and data analysis. This revolution in clinical evaluation enables professionals to produce high-quality, regulatory-compliant reports, while saving precious time. The future of the medical device industry looks set to be more efficient and innovative than ever.
Plan :
1. The evolution of regulatory requirements in clinical evaluation
Clinical evaluation has become crucial in the medical device sector, guaranteeing the safety and efficacy of products before they are marketed. Faced with ever-changing regulatory requirements, manufacturers must adapt to an increasingly complex and strict environment.
Regulation (EU) 2017/745 marked a major turning point, requiring robust clinical evidence to demonstrate medical device compliance. This development has made the drafting of Clinical Evaluation Reports (CERs) essential and paramount for manufacturers.
CERs, detailed documents summarizing the clinical data on a medical device, are essential for proving the product’s safety and efficacy. They play a key role in regulatory compliance, enabling manufacturers to meet the stringent requirements of the medical device market.
2. Traditional obstacles to writing clinical evaluation reports (CERs)
Writing clinical evaluation reports (CERs) for medical devices is a crucial process, but one that is often fraught with pitfalls.
Bibliographic research is the cornerstone of any solid CER. However, this step can quickly turn into a real headache for writers.
Why is this? Imagine navigating PubMed, Google Scholar, Cochrane, and other specialized databases, each with its own syntax rules and peculiarities.
For each medical device, experts must :
Developing specific search rules
Adapting these rules to each platform
Extract and consolidate results manually
This process, though rigorous, is time-consuming and prone to human error, jeopardizing the quality of the clinical evaluation.
Once the publications have been collected, the real marathon begins: manual analysis. Editors are faced with hundreds, sometimes thousands, of publications to review. Each article must be read, evaluated and synthesized to extract the information relevant to the clinical evaluation of the medical device in question.
This titanic task has several shortcomings:
Considerable time
Manually analyzing up to 400 publications can take weeks.
Risk of errors
Fatigue and monotony can lead to oversights or misinterpretations.
Inconsistencies
Different editors may have different approaches, threatening the coherence of the final report.
These traditional obstacles have a direct impact on the quality of CERs and, by extension, on the regulatory compliance of medical devices. Excessive time spent on manual research and analysis leaves less room for critical reflection and careful report writing.
Faced with these challenges, it’s becoming clear that traditional methods are reaching their limits. This is where artificial intelligence (AI) comes in, promising to radically transform the clinical evaluation process.
3. The advent of AI in clinical evaluation report (CER) writing
Artificial intelligence (AI) is transforming many sectors, and the clinical evaluation of medical devices is no exception to this revolution.
Advanced AI solutions, such as those offered by Opscidia, can automate much of this process. Using machine-learning algorithms and aggregating all scientific documents available on the web, these solutions can analyze millions of scientific publications in record time.
AI helps identify and extract relevant information
of research articles, allowing editors to concentrate on critical analysis and actual writing. This not only speeds up the process, but also improves the quality of the clinical evaluation.
AI can also automate the synthesis of information.
For example, Opscidia uses AI algorithms to synthesize several scientific documents into a coherent scientific synthesis.
By automating bibliographic research and data synthesis, and improving the accuracy and consistency of reports, AI overcomes many traditional obstacles. This translates into clinical evaluation reports of higher quality, produced faster and with enhanced regulatory compliance.
4. Les bénéfices concrets de l'IA pour les professionnels du secteur
Artificial intelligence saves precious time, improves report quality and ensures regulatory compliance, while paving the way for a veritable revolution in clinical evaluation.
Considerable time savings: bibliographic research and the analysis of scientific publications are time-consuming tasks that can take weeks or even months. Thanks to AI, these processes can be automated, reducing bibliographic research time by a factor of 2!
AI algorithms, like those integrated into the Opscidia platform, can query multiple databases simultaneously and extract relevant information and documents.
Improving quality by minimizing human error and ensuring consistent, rigorous data analysis: AI algorithms can be configured to meet regulatory compliance requirements, ensuring that search and analysis processes are transparent and traceable.
To illustrate in concrete terms the benefits of artificial intelligence in clinical evaluation report (CER) writing, we present a case study on our collaboration with ASPE, a firm specializing in CER writing. ASPE faced a number of challenges linked to the complexity of bibliographic research and the need to ensure regulatory compliance. Thanks to our Opscidia solution, we were able to automate much of the process, saving ASPE valuable time and improving the quality of its reports.
To find out in detail how ASPE transformed its CER writing process thanks to AI, click here to download the case study.
Download the case study on
How our customer automated the analysis of scientific literature for the drafting of clinical evaluation reports (CER).