What if AI could help reduce the 10-plus years it takes to get a new drug to market? That question has shaped much of my own product strategy thinking, and it’s exactly why I was drawn to Medable’s bold move with Agent Studio. It’s a rare look inside an enterprise AI platform built for one of the most regulated industries in the world—and a team that’s still figuring it out in real time.
In this episode of Just Now Possible, Teresa Torres talks with four members of the Medable team: Luke Bates (Product Leader, Agent Studio), Jen Brown (Product Manager), Matt Schoolfield (Product Designer), and Fiachra Matthews (Principal Architect). Listening through a product management lens, I focused on how their choices reflect a modern agentic AI strategy that balances speed, safety, and scale.
Medable does something uniquely hard: enabling global clinical trials across 100+ languages and accelerating drug-to-market timelines. That scope demands more than clever prompts—it requires a durable platform approach. Their answer is Agent Studio, a no-code/low-code platform for configuring and deploying agents across the clinical trial lifecycle.
What impressed me most was how clearly the platform’s primitives map to repeatable value: models, skills, knowledge bases, MCP connectors, versioning, and trigger types. In my experience, platforms win when these building blocks are composable, governed, and observable—exactly the direction Medable is taking.
You’ll also hear about the two agents they’ve built on top of it: an ETMF agent that automates document classification across 80,000-plus documents per year, and a CRA agent that monitors patient safety and data quality across 13 different clinical systems. For a domain where errors carry real human consequences, this is the right mix of automation and oversight.
Under the hood, their architecture choices echo what I’ve seen work in other high-stakes environments. They walk through RAG approaches at scale: embeddings vs. markdown hierarchies vs. just-in-time MCP retrieval, and explain Why they built custom MCPs with an authentication and credentialing wrapper. They also detail Context window management with sub-agents and automatic tool filtering—critical to keep agents focused and reliable as complexity grows.
Data alignment is often the unsung hero of agent reliability. I appreciated how they described How they built a unified ontology layer to map terminology across 13 different clinical data systems. Equally important, they show their paper trail: How they document agent intent → specification → test evidence to satisfy regulatory bodies. In a GXP context, this kind of lineage isn’t “nice to have”—it’s the price of admission.
Strategically, I love that Medable chose a platform approach to agents instead of one-off builds. They outline Three deployment models: Medable-built products, services-led custom builds, and self-serve platform access. This mirrors a healthy platform business model: prove value with first-party solutions, extend via services for complex needs, and unlock scale with self-serve—while keeping governance centralized.
Reliability is a theme throughout. They describe Evaluation design in a GXP-regulated environment: golden datasets, production monitoring, and the challenge of human feedback as ground truth. We also get a concrete picture of what human-in-the-loop really looks like when clinical decisions are on the line—tight feedback cycles, auditable interventions, and clear escalation paths.
Looking forward, they don’t shy away from ambition. The "full self-driving" vision for clinical trials and what it would take to get there is both provocative and grounded. My read: the path runs through stronger domain ontologies, standardized interfaces (MCP done right), eval-driven development, and relentless simplification of agent skills.
If you’re a product leader building in regulated spaces, this discussion is a masterclass in balancing innovation with compliance. The takeaways map cleanly to AI Strategy: define platform primitives, invest in retrieval-first pipeline patterns, design for context window management, lean into eval-driven development, and operationalize regulatory compliance from day one.
To dive deeper, listen to the conversation on Spotify or Apple Podcasts, and explore Medable’s broader platform work at medable.com. I left both inspired and practically equipped—an uncommon combo in today’s AI noise.
Inspired by this post on Product Talk.
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