AI Automation · Clinical Research Organizations
AI Automation for Clinical Research — Reduce Protocol Burden Without Sacrificing Data Quality
Clinical teams spend more time on documentation, coordination, and compliance paperwork than on the science. Manual data entry, deviation tracking, and regulatory prep consume weeks that should be accelerating your trials.
Fixed-fee projects · Source code ownership · 30-day post-delivery support
Data Entry Is Not Where Your Researchers Should Spend Their Time
The average CRA spends 30–40% of their working hours on administrative tasks that require no scientific judgment — status reports, site communications, document filing, eligibility confirmation. That is capacity that should be going toward monitoring quality and site support.
Regulatory compliance overhead is growing, not shrinking. ICH E6(R3) documentation requirements, 21 CFR Part 11 audit trails, protocol amendment management — these tasks are mandatory and time-consuming. The organizations keeping pace are systematizing the coordination layer.
We build AI agents for CROs and sponsor teams that handle document processing, eligibility pre-screening, and site communication — so your clinical staff can focus on oversight, quality decisions, and the relationships that actually move your trials forward.
What We Automate for Clinical Research Organizations
Each workflow below is a discrete AI agent — built, tested, and deployed against your specific systems. Not a Zapier template. Not a chatbot. A working system.
Patient Eligibility Pre-Screening
An agent that reads patient records against your protocol inclusion and exclusion criteria and flags eligible candidates for CRA review. Pre-screening time drops from 30+ minutes per record to under 2 minutes — with a documented audit trail for every assessment.
Protocol Deviation Tracking
Automated detection and logging of deviations from incoming CRF data. The agent categorizes by severity level, routes minor deviations to the site coordinator and major deviations to the clinical lead, and generates the deviation report in your required format.
Regulatory Document Preparation
An agent that assembles IND amendments, site initiation documents, and regulatory binders from your source templates and trial-specific data — auto-populating fields, flagging missing information, and generating a completeness checklist before submission.
Site Coordinator Communications
Automated query generation, site visit reminders, outstanding data point follow-ups, and protocol update notifications — all tracked in your CTMS with response monitoring. Coordinator communication that previously consumed 2+ hours per day runs automatically.
CRF Data Extraction and Validation
An agent that extracts data from electronic or scanned case report forms, validates entries against expected ranges and protocol definitions, flags discrepancies for data manager review, and pushes clean data into your clinical database — with a full audit log.
Trial Status Reporting
Weekly automated status reports for sponsor and management review — enrollment progress, screen failure rates, outstanding queries, site performance, and projected timelines — pulled from your CTMS and assembled without manual data pulls.
Why General Automation Tools Do Not Work in Regulated Environments
Zapier can move a file from one folder to another. It cannot read a case report form, validate entries against protocol-defined ranges, categorize a deviation by severity, notify the appropriate clinical lead, generate a regulatory-formatted deviation report, and log everything in your CTMS with an ICH-compliant audit trail. That is a multi-step, logic-heavy workflow that requires an agent built with your specific regulatory requirements in mind — not a general-purpose automation platform.
Zapier / Make
Great for simple, linear triggers. Breaks on multi-step logic, error handling, and AI decision-making.
ChatGPT / Copilot
Answers questions well. Cannot hold state, use your tools, or run workflows without a human in the loop.
What We Build
AI agents that connect to your real systems, follow conditional logic, handle exceptions, and run end-to-end.
What Results Look Like
We are pre-revenue and building our first case studies. Below is market data from operators in adjacent industries who have implemented similar systems.
21+ hours reclaimed per employee per week
A professional services firm running comparable high-documentation workflows reduced client intake from 30 minutes to 3 minutes, automated 8 hours per week of follow-up coordination, and cut document processing from 15 hours to 2 hours per week — reclaiming the equivalent of $163,800 per year in billable capacity per employee.
What Every Engagement Includes
Every project is fixed-fee, scoped upfront, and delivered with full source code ownership. No lock-in. No hidden costs. No strategy decks without working software.
- Working system delivered in 2–10 weeks
- Full source code — you own everything we build
- Documentation so your team can maintain it
- 30-day post-delivery support included
- Direct founder access throughout the engagement
- Fixed-fee pricing — no hourly surprises
Other Industries We Work With
Dental Practices
Your front desk is managing scheduling, recalls, insurance pre-authorizations, and patient questions simultaneously — across multiple software systems. It is not sustainable, and patients are falling through the cracks.
See automationsLaw Firms
The average lawyer spends 2–3 hours per day on non-billable administration: intake paperwork, client status updates, invoice follow-ups, calendar management. That is up to 30% of your working day generating zero revenue.
See automationsReady to Talk Through Your Specific Workflows?
Book a free 30-minute discovery call. We will map your highest-cost manual workflows, tell you what is automatable today, and give you a realistic scope and timeline — no commitment required.
Toronto-based · Fixed-fee · You own everything we build