AI platform for a leading regulatory affairs service provider

The challenge: Producing clinical evaluations efficiently and with regulatory confidence

The EU MDR has raised the bar for clinical evaluations dramatically, including for product classes that previously required little effort. A complete clinical evaluation ties up staff for several weeks. Projects involve hundreds of literature references and dozens of customer documents. The most time-consuming part isn't the expert reading itself, but the mechanical structuring that follows: extracting content, filling in tables, and 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. Project leads decide exactly which tasks MAIA takes on and what the results should look like. Work that once meant hours of manual effort now runs far more efficiently. MAIA handles the time-consuming structuring work, while the team focuses on what genuinely requires expertise: the professional analysis and evaluation of the content.

The result: More capacity for depth

With MAIA, novineon CRO has made a decisive leap in efficiency without compromising on regulatory quality. The team steers the entire process: from defining the task and MAIA-supported extraction to the expert evaluation of the results. What changes isn't the diligence, but the time spent on repetitive intermediate steps. On new clients or very large projects in particular, MAIA helps the team build a structured overview quickly. The substantive review and evaluation always remain with the team.

The result: The project team works faster, more consistently, and with more capacity for what really matters: subject-matter depth and close client relationships.

Use Cases

Table extraction from literature data

The responsible staff define the relevant parameters, e.g. safety or performance data, and MAIA extracts them from scientific publications into predefined table formats in a structured way. The results are then reviewed by experts.

Literature updates for existing evaluations

When updating clinical evaluations, MAIA helps extract relevant data from new publications and incorporate 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

On very large client projects, MAIA helps open up big document packages systematically and pinpoint relevant product information. The substantive review and evaluation always stays with the team.

Example prompts‍

Prompting is possible in all languages

"Extract all data on complication rates from these 10 publications and fill in the attached table."

"Compare the wording across the uploaded documents and highlight any differences."

"Create a structured overview of the relevant information from the uploaded publications."

The responsible staff define the extraction criteria in advance, such as relevant safety or performance parameters, and then evaluate the results MAIA delivers from a professional standpoint. This keeps content quality in expert hands at all times.

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Key Takeaways

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