Build, validate, & share AI workflows for clinical operations

Develop rigorous prompts and rules unique to your clinical operations.

The easiest way to use AI on your own terms

Start with a library of prompts that fits into the way you already work with the tools you already use.

Select regulatory frameworks that apply

Build AI workflows with confidence

Validate using our mock datasets

Copy, paste, and run prompts in your own tools

If you can develop a drug, you can develop a prompt

Create workflows your whole team can use—safely, consistently, and without becoming AI experts.

Build prompts that work

Structure and context built in. Designed for clinical operations, not chat.

Validate against mock data

Test your prompts with mock data before you rely on them.

Iterate & share with colleagues

Track changes and share validated prompts with your team.

Compatible with the tools you already use

Build prompts in Polytrial, export and run them anywhere. You're never locked in, and your data stays yours.

Get started with purpose-built prompts for clinical operations

Show your work and keep your entire team aligned. Copy into ChatGPT, Copilot, or your own IT-approved system.

eTMF Auto-Filer & Gap-Finder

Regulatory

Protocol → Visit Summary & Checklist Assistant

Site activation

ICF Builder + Regulatory Alignment Assistant

Regulatory

Audit & Inspection Readiness Simulator

Validate AI output using our library of regulatory frameworks

Choose the frameworks that apply to your trial. Get real-time validation as you write.

21 CFR Part 58 - Good Laboratory Practice

21 CFR Part 58 establishes the federal regulatory standards for conducting nonclinical laboratory studies (safety studies) that support applications for research or marketing permits for FDA-regulated products. It mandates rigorous requirements for organizational structure, facility management, personnel qualifications, and Standard Operating Procedures (SOPs) to ensure studies are planned, performed, monitored, and reported consistently. Use this framework to ensure the quality and integrity of safety data submitted to the FDA are reliable and verifiable.

GCP E6 - Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Use this framework to ensure that the rights, safety, and well-being of trial participants are protected and that the data generated from clinical trials is credible, reliable, and acceptable to regulatory authorities worldwide.

Guidance for best practices for clinical trials

This 2024 guidance serves as a global framework to strengthen clinical trial ecosystems by establishing universal standards for efficiency, scientific quality, and ethical conduct. Use this framework to minimize research waste and foster patient-centered, inclusive research that is integrated into health systems to generate reliable evidence for both routine and emergency health needs.

21 CFR Part 11 - Electronic Records, Electronic Signatures

21 CFR Part 11 establishes the United States Food and Drug Administration's (FDA) criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and legally equivalent to paper records and handwritten signatures. Use this framework to verify your processes ensure the authenticity, integrity, and confidentiality of electronic data while maintaining strict compliance and data security.

Considerations for the Use of Artificial Intelligence

These guidance documents establish a risk-based framework to ensure that AI models used in drug development and medical devices are reliable, transparent, and free from bias, setting clear standards for their credibility and safety. Use this framework to design validation studies and documentation strategies (such as defining a "Context of Use" and monitoring data drift) to prove to the FDA that their AI tool performs accurately and ethically throughout its entire lifecycle.

Frequently asked questions

What is Polytrial?

A platform for authoring, validating, and sharing AI workflows for clinical research. You model your processes, ground them in regulatory frameworks, and export to the AI tools you already use.

How is this different from using ChatGPT?

ChatGPT is great for one-off tasks. Polytrial helps you build repeatable, validated workflows that your whole team can use consistently—with structure, guardrails, and audit trails.

Do I need IT approval?

No. Your workflows run in tools you already use (ChatGPT, Copilot, etc.), so we never process study data. Nothing to install, no new vendor to vet.

Who is this for?

Research teams who want to standardize how they use AI—without waiting for IT or becoming AI experts. If you're doing protocol review, data cleaning, or monitoring, this is for you.

What does validation mean?

Before you run a workflow, you test it against mock trial data in our sandbox. You see how it performs, catch edge cases, and build confidence before it touches real study data.