Medable and Agentic AI: A Revolution in Clinical Trials

Medable, a pioneering company in the field of clinical trials, has set out to revolutionize the drug market entry process through its innovative platform, Agent Studio. This initiative aims to significantly reduce the time, often exceeding ten years, required for a new drug to reach the market.

In an episode of "Just Now Possible," Teresa Torres speaks with four prominent members of the Medable team: Luke Bates, Product Lead of Agent Studio, Jen Brown, Product Manager, Matt Schoolfield, Product Designer, and Fiachra Matthews, Principal Architect. Together, they explain how Medable designed Agent Studio, a no-code or low-code platform, to configure and deploy agents throughout the clinical trial lifecycle.

Medable's Innovative Agents

Agent Studio has developed two main agents: the ETMF agent and the CRA agent. The ETMF agent is designed to automate the classification of over 80,000 documents per year, thereby simplifying a process that is often labor-intensive and error-prone. The CRA agent, on the other hand, ensures rigorous monitoring of patient safety and data quality across 13 different clinical systems, thus guaranteeing enhanced data integrity and regulatory compliance.

An Architecture Tailored to Regulatory Needs

The underlying architecture of the platform includes large-scale RAG (Rapid Access Gateway) management and large-scale context management. Medable chose to build Custom Competency Models (MCPs) with an authentication layer to meet the stringent requirements of GXP-regulated environments. The design of assessments includes gold-standard datasets and production monitoring, while integrating human feedback as a reference truth.

A Flexible and Comprehensive Approach

Medable enables clinical trials in over 100 languages, thereby accelerating drug market entry timelines. The platform offers three deployment models: products built by Medable, custom builds led by services, and self-service access to the platform. This flexibility allows pharmaceutical companies to choose the approach that best fits their specific needs.

Towards Complete Automation

The Medable team envisions "fully autonomous driving" for clinical trials, an ambitious goal that would require significant advancements in the integration and automation of clinical processes. To achieve this goal, Medable meticulously documents the intent of the agents, specifications, and testing evidence to satisfy regulatory bodies. This rigorous approach is essential to ensure that the agents operate reliably and in compliance with industry standards.

In summary, Medable, through Agent Studio, positions itself at the forefront of innovation in clinical trials, offering solutions that could transform the way drugs are developed and made available to the public.