Dr. Louise Liu, founder and CEO of Hill Research, joined the Future of Drug Discovery podcast to discuss how generative AI is speeding up statistical programming for FDA submissions. The episode, released May 20, 2026, focuses on one of the slower steps in clinical development: producing the statistical data package that supports a regulatory filing. 

According to the episode description, a single Phase 3 trial typically takes about eight programmers, six months, and $8 million to produce this package. Hill Research says it completes the same work with one person in 90 minutes using generative AI. 

What AI Statistical Programming Means for Clinical Trial Submissions 

After a clinical trial ends, statistical programmers turn raw trial data into the tables, figures, and listings (TFLs) that sponsors submit to regulators. The work is detailed, heavily validated, and largely manual, which makes it a frequent bottleneck between trial completion and submission. 

In the conversation, Liu covers how Hill Research’s technology works, how the FDA views the use of AI in submissions, and who is accountable for AI-generated outputs, a question pharmaceutical executives are asking. She also discusses what the next decade of clinical development could look like if the rest of the drug development pipeline catches up. 

About Hill Research 

Princeton, New Jersey-based Hill Research is an AI-powered clinical research company. Its TriClick™ platform transforms raw clinical trial data into regulatory-ready TFLs while maintaining human oversight for compliance and quality. Jetstream Venture Fund invested in Hill Research in April 2026. 

Frequently Asked Questions 

What is statistical programming in clinical trials? 

Statistical programming converts raw clinical trial data into analysis datasets and the tables, figures, and listings (TFLs) used in regulatory submissions to agencies such as the FDA. It is labor-intensive, typically requiring teams of programmers and extensive validation. 

How does Hill Research use AI for FDA submission work? 

Hill Research’s TriClick™ platform uses generative AI to automate statistical programming for clinical trials. The Future of Drug Discovery episode describes the company producing a Phase 3 data package with one person in 90 minutes, with human oversight retained for compliance. 

Read the Original Article: AI Statistical Programming for FDA Submissions – Louise Liu – #18