Picture this: You've developed a breakthrough diabetes treatment that could change millions of lives. But before it reaches a single patient, you're drowning in a sea of regulatory paperwork. Welcome to Novo Nordisk's reality.

The global pharmaceutical giant faced a crushing bottleneck in creating the extensive documentation required to bring new medicines to market. We're talking Clinical Study Reports (CSRs) up to 300 pages long, device protocols, and patient guides—all critical for regulatory approval.

Here's the kicker: Their staff writers could only churn out 2.3 CSRs per year. Each document took over 10 weeks to complete through manual processes. And here's where it gets expensive—every day of delay could cost up to $15 million in potential revenue. More importantly, patients waited longer for treatments that could transform their lives.

Enter NovoScribe, Novo Nordisk's internal AI-powered platform that's like having a team of expert writers working at superhuman speed. This isn't just another chatbot—it's a sophisticated system that automates the production of complex regulatory documentation while maintaining the precision required in a heavily regulated industry.

But here's what makes NovoScribe special: it empowers non-technical team members to prototype features and expand use cases.

Think of it as democratizing AI development—suddenly, your domain experts aren't waiting for IT to build solutions. They're building them themselves.

NovoScribe runs on Anthropic's Claude models (including Claude Code) via Amazon Bedrock, with MongoDB Atlas serving as the vector database. The secret sauce? Retrieval-augmented generation (RAG) that grounds AI outputs in expert-approved data—crucial when you're dealing with life-or-death regulatory requirements.

Claude Code is the game-changer here, enabling rapid prototyping by non-technical staff. It's like giving your scientists a magic wand to build their own tools.

Let's be honest—this wasn't a plug-and-play solution. Integrating legacy systems and ingesting unstructured data took months of careful work. In a regulated industry like pharmaceuticals, you can't move fast and break things. You move deliberately and build things right.

Ensuring regulatory compliance and security required close collaboration with Anthropic. Every step had to be bulletproof because when you're dealing with drug approvals, there's no room for error.

Ready for some jaw-dropping metrics? NovoScribe delivered results that sound almost too good to be true:

• 90% reduction in CSR writing time (from 10+ weeks to 10 minutes)
• 50% faster review-to-approval cycles
• 95% cut in device protocol resources
• Patient documentation creation reduced from months to minutes
• Positive feedback from regulators (the ultimate validation)

Translation: Medicines are reaching patients faster, and that $15 million daily cost of delay? Dramatically reduced.

• Target High-Value Bottlenecks:Novo Nordisk didn't try to AI-ify everything. They laser-focused on their biggest pain point—regulatory documentation—and achieved disproportionate value.
• RAG is Non-Negotiable for Regulated Industries: You can't just hope AI gets it right. Ground your outputs in verified, expert-approved data.
• Empower Your Domain Experts: The magic happens when you put AI tools directly in the hands of people who understand the business problem, not just the technology.
• Human-Centered AI Wins: This isn't about replacing people—it's about freeing them from tedious tasks so they can focus on strategic, high-value work.

NovoScribe has transformed from a CSR-focused tool into a comprehensive documentation platform, expanding to device protocols and patient materials. Documentation that once required entire departments now needs just a single user. Review cycles have been halved, and most importantly, medicines reach patients faster.

But Novo Nordisk isn't stopping there. Claude is being piloted in medical affairs and for automating Common Technical Documents (CTDs). They're exploring applications in data analysis and infrastructure modernization.

That's not just AI transformation—that's AI with purpose.

🐯 Tiger Takeaway:

NovoScribe is a masterclass in focused AI transformation. By automating a single, high-friction process, Novo Nordisk achieved massive efficiency gains and accelerated time-to-market for new medicines. The lesson? Don't boil the ocean—find your biggest bottleneck and AI the hell out of it.

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