AI platform for a leading regulatory affairs service provider
Facts & figures
The challenge: producing clinical evaluations efficiently and with regulatory certainty
The EU MDR has massively increased the requirements for clinical evaluations, including for product classes that used to require little effort. A complete clinical evaluation ties up the responsible staff for several weeks. Projects comprise several hundred literature references and dozens of customer documents. The most time-consuming part is not the expert reading but the mechanical structuring that follows: extracting content, filling in tables, checking documents for consistent wording.
The solution: MAIA as an extraction and knowledge platform
novineon CRO uses MAIA as its central knowledge and extraction platform. The project leads decide precisely which tasks MAIA takes on and what the results should look like. What used to mean hours of manual work now runs much more efficiently. MAIA takes over the time-consuming structuring work, while the team can focus on what requires real expertise: the expert analysis and assessment of the content.
The result: more capacity for expert depth
With MAIA, novineon CRO has made a decisive leap in efficiency without compromising on regulatory quality. The employees responsible steer the entire process: from defining the task, through the MAIA-supported extraction, to the expert evaluation of the results. What changes is not the level of care but the time that has to be spent on repetitive intermediate steps. Especially with new customers or very extensive projects, MAIA helps to get a structured overview quickly. Getting to grips with the content and assessing it always remains with the team.
The result: the project team works faster, more consistently and with more capacity for what really counts: expert depth and closeness to customers.
Use cases
Extracting tables from literature data
The employees responsible define the relevant parameters, e.g. safety or performance data, and MAIA extracts them in a structured way from scientific publications into predefined table formats. The results are then reviewed by the experts.
Literature updates for existing evaluations
When clinical evaluations are updated, MAIA helps to extract relevant data from new publications and work it into the existing evaluation in a structured way. The project leads assess the literature, decide on its relevance and determine where the new content is added.
Project onboarding & document analysis
For very extensive customer projects, MAIA helps to work through large document packages systematically and to identify relevant product information in a targeted way. Getting to grips with the content and assessing it always remains with the team.
Example prompts
The employees responsible define the extraction criteria in advance, such as relevant safety or performance parameters, and then evaluate the results delivered by MAIA from an expert perspective. This way, the quality of the content always stays in the hands of the experts.
In summary
- With MAIA, novineon CRO reduces the time spent extracting information from documents by 50%.
- At novineon CRO, MAIA processes more than 170 million words of clinical knowledge for clinical evaluations under the EU MDR.
- novineon CRO runs around 2,000 search queries a month through MAIA.
- Using MAIA increases productivity at novineon CRO by 5.4%.
“For the clinical evaluation of medical devices, I review extensive literature every day. I do the content assessment and categorisation myself – MAIA collects the data and puts it into tables following my template. What used to take considerable effort is noticeably reduced, so I can focus on what matters: assessing and interpreting the results.”
Let’s get started.
In a first intro call, we’ll work out together what a good start with MAIA looks like for you.
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