New Tufts CSDD Analysis Finds AI Agents Can Deliver Up to $21 Million in Net Financial Value Per Drug Development Program and Up to 82x ROI

PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., the leading technology platform for agentic clinical development, today announced a new Tufts Center for the Study of Drug Development (CSDD) analysis showing that an AI clinical monitoring agent can deliver net financial gains as high as $21 million per drug development program and 82 times the return on investment. The findings are based on benchmarked oncology program and clinical trial data from Tufts CSDD and contract value and experience data from Medable.

The Tufts CSDD analysis specifically assessed the impact of Medable’s Clinical Monitoring Agent across three top-line metrics:

1. Expected net present value: The agent showed eNPV gains of approximately $7.5 million (phase 2 trial), $11.3 million (combined phase 2 and phase 3) development, and $21 million (phase 3 trial).
2. Overall return on investment: The study found an estimated ROI of 64x for phase 2 and 82x for phase 3 clinical trials.
3. Direct operating cost savings: Tufts CSDD estimated direct operating cost reductions in on-site monitoring per clinical trial of approximately $4.4 million per phase 2 and $5.6 million per phase 3 study.

“To our knowledge, this is the first time that eNPV modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution deployed to support a drug development program,” said Ken Getz, Tufts CSDD Executive Director. “The financial value created by the investment and deployment of the monitoring agent was driven by operational efficiencies such as the reduction in the number of on-site visits and reduced travel costs as well as accelerated enrollment and database lock timelines.”

Additional analysis identified and valued administrative off-site monitoring task efficiencies of approximately $600,000 (phase 2) and $1.7 million (phase 3). These savings reflect clinical research associate time that could be reallocated to other studies and were not included in the eNPV calculations.

The analysis also found that agentic AI can accelerate clinical development by approximately 18 weeks. By shortening activities on the critical path of development, agents help sponsors complete studies sooner, advancing regulatory submission and potential commercialization while increasing the expected financial value. Key contributors include:

- Faster patient enrollment, reducing enrollment timelines by approximately 109–119 days
- Earlier database lock, shortening closeout activities by about two weeks
- Earlier realization of future revenue and lower development costs

“The potential impact is magnified when applied across a large oncology portfolio,” said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. “For a sponsor with 20 active indications, deploying a clinical monitoring agent across phase 2 and 3 studies could generate as much as $226 million in incremental portfolio eNPV. For a sponsor with 50 active indications, that figure could jump to as much as $565 million. Bottom line? We now have evidence demonstrating sizable value creation of agents in clinical research, helping break longstanding barriers.”

In addition to these high-level findings, Tufts and Medable will publish a detailed, peer-reviewed paper later this year. Sign up to be the first to receive the final published paper here.

Tufts CSDD Analysis Methodology

Medable partnered with Tufts CSDD, the leading independent research group on clinical development economics, to empirically answer the question: To what extent can clinical monitoring agents improve trial performance, and do those translate into measurable economic value for drug developers? Medable provided operational data – including time savings and agent cost – from its Clinical Monitoring Agent modeled in an oncology development program. Tufts CSDD applied the expected Net Present Value (eNPV) framework, a widely accepted method for quantifying the financial impact of innovation investments, to assess the value created by the AI agent.

About Tufts Center for the Study of Drug Development (CSDD)

The Tufts Center for the Study of Drug Development is an independent academic research center that conducts objective analyses of the scientific, economic, and policy factors affecting pharmaceutical innovation and clinical development.

About Medable

Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. Learn more at medable.com