Clinical Trial Admin Automation

Let an AI agent handle subject calendars, IRB reports, and compliance checklists—so you can focus on running your studies, not chasing paperwork.

You’re a research coordinator juggling Excel trackers, Outlook calendars, and endless email threads just to keep your study on track. Every week, you spend hours copying visit dates, preparing regulatory forms, and following up on overdue tasks. The risk of missing a deadline or making a documentation error is always looming, and the workload never lets up.

An AI agent that automates subject scheduling, regulatory paperwork, and compliance tracking for clinical research coordinators.

What this replaces

Update subject visit calendars in Excel by hand
Draft IRB and regulatory reports from scratch in Word
Send appointment reminders to subjects via Outlook email
Compile adverse event logs from REDCap into summary tables
Track protocol compliance tasks using shared Google Sheets

The hidden cost

What this is really costing you

In clinical research, coordinators at hospitals and academic sites spend most of their week buried in admin—manually updating subject visit logs in Excel, drafting IRB forms in Word, and tracking compliance tasks with email reminders. These repetitive tasks eat up time that could be spent with subjects or supporting investigators. Manual data entry increases the risk of protocol deviations and audit findings, while constant deadline pressure leads to burnout.

Time wasted

12-14 hrs/week

Every week, burned on work an AI agent handles in minutes.

Money lost

$31,200/year

In salary, missed revenue, and operational drag — annually.

If you keep ignoring it

Missed IRB deadlines can trigger compliance violations and audits. Errors in subject tracking may delay enrollment or jeopardize funding. High admin burden drives staff turnover and puts study timelines at risk.

Cost estimates derived from U.S. Bureau of Labor Statistics occupational wage data and O*NET task analysis.

Return on investment

The math speaks for itself

Today — without agent

13 hrs/week

of manual work

$31,200/year/ year

With your AI agent

2 hrs/week

agent-handled

$4,800/year/ year

You save

$26,400/year

every year, reinvested into growing your business

Estimates based on U.S. Bureau of Labor Statistics median salary data and O*NET task importance ratings from worker surveys. Time savings assume 80% automation of eligible task components.

Jobs your agent handles

What this agent does for you

Complete jobs, handled end-to-end — so your team focuses on what matters.

Schedule Subject Visits Instantly

You ask your agent to coordinate all subject visits for the next phase, and it generates a visit calendar with appointment reminders for each participant.

Prepare IRB Progress Reports

You ask your agent to draft the latest IRB progress report, and it compiles all required data into a formatted document ready for submission.

Screen Potential Subjects

You ask your agent to review new patient records against protocol criteria, and it delivers a list of eligible candidates with supporting notes.

Track Adverse Events

You ask your agent to log and summarize all adverse events from the past month, and it produces a report highlighting cases needing follow-up.

How to hire your agent

1

Connect your tools

Link your clinical trial management, data capture, and team communication tools to the agent.

2

Tell your agent what you need

Type: 'Screen these new patient records for eligibility based on protocol 2024-01.'

3

Agent gets it done

The agent returns a summary table of eligible and ineligible subjects with notes on inclusion or exclusion criteria.

You doing it vs. your agent doing it

Manually coordinate with subjects, check protocol windows, and send reminders by email.
Agent generates visit schedules and sends reminders automatically.
3 hrs/week
Draft protocol worksheets and IRB reports from scratch, referencing multiple sources.
Agent compiles and formats required documents for review and submission.
4 hrs/week
Collect reports, enter data, and summarize for investigators and agencies.
Agent logs events and produces summary reports with flagged follow-ups.
2 hrs/week
Review medical records and protocol criteria for each candidate.
Agent analyzes records and delivers eligibility summaries for review.
3 hrs/week

Agent skill set

What this agent knows how to do

Automated Visit Scheduling

Pulls protocol schedules from Medidata CTMS and generates personalized subject calendars with appointment reminders sent via Outlook.

Eligibility Review

Analyzes new patient records from Epic and flags candidates who meet inclusion criteria, creating a summary for investigator sign-off.

Regulatory Document Preparation

Drafts IRB progress reports and adverse event narratives using data from REDCap, delivering formatted Word files for submission.

Adverse Event Summarization

Monitors adverse event entries in REDCap and compiles monthly summary tables, highlighting cases needing immediate follow-up.

Protocol Compliance Tracking

Checks scheduled activities against protocol milestones in Medidata, sending alerts for overdue or missing documentation.

Enrollment Status Reporting

Tracks informed consent and enrollment numbers in OnCore, updating real-time dashboards for study teams and sponsors.

AI Agent FAQ

The AI agent integrates directly with Medidata CTMS, Epic, REDCap, and OnCore via secure API connections. You can authorize access to the platforms your site uses, and the agent pulls only the data needed for each task. No manual data exports are required.

All data processed by the agent is encrypted in transit using TLS 1.3 and never stored after task completion. Access logs are maintained for all actions, and the agent operates within your institution’s firewall. No data leaves your environment.

No, the agent automates repetitive admin work but does not replace clinical judgment. You review all eligibility summaries and regulatory drafts before submission. The agent is designed to support, not substitute, the coordinator’s expertise.

Yes, you can upload updated protocol documents, and the agent will adjust scheduling, eligibility, and compliance checks accordingly. It flags any inconsistencies between previous and current versions for your review.

The agent currently supports English-language documentation and integrates with Medidata, Epic, REDCap, and OnCore. Multi-language support and additional EDC integrations are planned for future releases.

See how much your team could save with AI

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