How Novo Nordisk Uses Claude to Generate Clinical Study Reports in Minutes
Novo Nordisk built NovoScribe using Claude Code to automate clinical study report generation, cutting documentation time from 10+ weeks to 10 minutes.
Impact
10 weeks → 10 minutes
Clinical study report creation time
95%
Resource reduction for device verification
2.3 (manual baseline)
CSRs per staff member per year
Challenge
Regulatory documentation including 300-page clinical study reports was a critical bottleneck, costing up to $15M per day of market delay.
Solution
Built NovoScribe using Claude Code to automate generation of regulatory-grade clinical documentation organization-wide.
Tools & Technologies
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Full Story
Novo Nordisk, the global pharmaceutical company behind Ozempic, faces one of the most documentation-intensive processes in any industry. Each day of delay in bringing a new medicine to market costs up to $15 million in potential revenue.
The challenge was clinical study reports—documents up to 300 pages long required for regulatory submissions. Staff averaged just 2.3 reports per year through manual processes, making this a critical pipeline bottleneck.
Novo Nordisk built NovoScribe, an internal AI platform using Claude Code and MongoDB Atlas. The platform automates generation of regulatory-grade clinical documentation and enables non-technical team members to prototype features, producing content that regulators respond to positively.
Results were transformative: report creation dropped from 10+ weeks to 10 minutes. Device verification protocols required 95% fewer resources. The platform has expanded from clinical trials to device testing and patient materials.
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