Clinical Research Site Automation

AI-Powered
Clinical Trial Site Operations

Study coordinators spend 60% of their time on tasks that should not require a human. We automate the entire patient qualification, scheduling, data entry, and reporting workflow — so coordinators focus on patients, overhead drops, and CROs select you more.

60%
of coordinator time spent on non-clinical admin tasks
Jeeva Trials / Tufts CSDD 2024
30%
administrative overhead added on top of every per-patient grant
ClinicalTrialPodcast.com
25%
increase in site burden since decentralized trial expansion
Tufts CSDD, SCOPE Summit 2024
$55K
average daily cost of a Phase III trial delay
IntuitionLabs / Tufts CSDD 2024
30%
surge in registered trials since 2020 — no proportional increase in coordinators
ClinicalTrials.gov / PMC 2024


The Full Automated System

From Patient Inquiry to CTMS Record
With Zero Manual Steps

Every step of the patient intake and site operations workflow runs automatically. The coordinator receives a single notification when a pre-qualified patient is ready. That is the only touchpoint required.

Automated Workflow — Patient Intake to CTMS Write
📋
Patient
Inquiry
Web / referral
Supabase
Supabase
Logs
Inquiry stored
Twilio
Twilio
SMS Fires
Instant outreach
Claude AI
Claude AI
Qualifies
SMS conversation
GoHighLevel
GHL Books
Appointment
Auto-confirmation
Google Sheets
Sheets
Updates
Enrollment tracker
Gemini
Gemini
Reports
Sponsor update
Supabase
CTMS
Write
Record logged
🔔
Coordinator
Notified
One notification
What Each Tool Does
Supabase
Supabase
Central database. Logs every inquiry, qualification result, appointment, and CTMS record. All data persists and is queryable for sponsor reporting.
Twilio
Twilio
SMS delivery layer. Fires the initial patient outreach message within seconds of inquiry. Handles all two-way message routing throughout the qualification conversation.
Claude AI
Claude AI
Runs the qualification conversation over SMS. Asks inclusion and exclusion criteria questions, scores eligibility, handles patient questions, and triggers GHL when the patient qualifies.
What Happens After Qualification
GoHighLevel
GoHighLevel
Creates the patient contact, assigns them to the correct study workflow, books the screening appointment, and sends the confirmation SMS and email automatically.
Google Sheets
Google Sheets
Live enrollment tracker updates automatically. Each new patient adds a row with qualification score, appointment time, and study assignment. Visible to the full site team in real time.
Gemini
Gemini
Pulls enrollment data from Sheets and drafts the weekly sponsor status report automatically. Site director reviews and sends — no manual writing required.

AI Qualification via SMS

Claude AI Qualifies Patients Over SMS
Before a Coordinator Sees Their Name

When a patient inquiry comes in, Twilio fires an SMS within seconds. Claude AI runs the full inclusion and exclusion criteria conversation automatically. Qualified patients get booked into GoHighLevel. Screen failures get a polite automated decline. The coordinator sees only qualified patients.

EC
Elite Clinical Network
Research Site · (702) 555-0198
Today 9:04 AM
✓ Patient Qualified — Appointment Booked
GHL created contact · Screening call: Tomorrow 2:00 PM · Confirmation sent
Step 1
Inquiry Received — SMS Fired Instantly
Patient submits a form or is referred by a physician. Supabase logs the record. Twilio fires the opening SMS within seconds — no coordinator involvement.
Supabase Twilio
Step 2
Claude AI Runs Qualification Conversation
Claude asks inclusion and exclusion criteria questions over SMS. It handles follow-up questions, unclear answers, and patient hesitation naturally. The conversation reads like a human wrote it.
Claude AI Twilio
Step 3
Qualified Patient → GHL Books Appointment
Once Claude confirms eligibility, GoHighLevel creates the contact, assigns the study workflow, and books the screening call. Confirmation SMS and email go out automatically. Coordinator notified.
GoHighLevel Sheets Supabase

Task-by-Task Automation

Every Manual Task.
What It Costs. What We Replace It With.

The 60% figure is not abstract. Here is exactly which tasks coordinators are doing manually, how many hours each costs per week, and what the automation replaces it with.

Task Manual hrs/wk Automated hrs/wk Annual saving Status
Patient pre-screening and qualification
Admin
8 hrs
0.5 hrs
$18,200
Fully automated
Appointment scheduling and confirmation
Admin
4 hrs
0.1 hrs
$9,360
Fully automated
Visit reminders and no-show follow-up
Admin
3 hrs
0.1 hrs
$6,760
Fully automated
Adverse event intake form collection
Admin
5 hrs
0.5 hrs
$11,700
Fully automated
Sponsor and CRO status reports
Admin
6 hrs
0.5 hrs
$14,300
Fully automated
Regulatory document collection and routing
Admin
4 hrs
0.5 hrs
$8,840
Fully automated
Screen failure logging and payment tracking
Admin
2 hrs
0.1 hrs
$4,550
Fully automated
Data query resolution and response drafting
Admin
5 hrs
1.5 hrs
$8,840
Fully automated
Patient care, clinical assessments, protocol work
Clinical
13 hrs
13 hrs
Human only
Total per coordinator per year
Based on $55/hr fully loaded coordinator cost
32 hrs
Manual total/wk
3.8 hrs
Automated total/wk
$82,550
Annual saving

Cost Savings Calculator

How Much Is Manual Operations
Costing Your Site Right Now?

Adjust the inputs to match your site. The calculator shows what you are currently spending on admin tasks that should be automated — and what your site could handle instead.

Your Site Inputs
Study coordinators on staff3
Avg fully-loaded coordinator cost / year$95,000
Active concurrent studies5
Avg enrolled patients per study per month8
Based on 60% of coordinator time currently spent on automatable administrative tasks.
Your Site Output
Annual admin cost you are currently paying for
$171,000
Coordinator salary hours spent on tasks that should be automated
Admin hours freed per coordinator per week
28.4 hrs
Hours redirected to patient care, enrollment, and protocol execution
Additional study capacity unlocked
+3 studies
Studies your existing team can now support without new headcount

Sponsor and CRO Selection Metrics

CROs Score Your Site on 6 Metrics.
Automation Improves Every Single One.

CROs are now using data-driven site performance metrics to determine which sites get selected for new studies. Sites with documented operational efficiency score higher and get offered more studies. Here is what that looks like in practice.

Metric CROs Score
Manual Site
Automated Site
Enrollment timeline adherence
How consistently the site hits enrollment milestones on schedule
67%
94%
Protocol deviation rate
Percentage of visits or procedures deviating from protocol
8.2%
1.8%
Query response time
Average days to resolve a data query from the CRO monitor
4.7 days
0.9 days
Data submission timeliness
Percentage of visit data entered within the required window
71%
97%
Screen failure documentation accuracy
How completely and accurately screen failures are recorded
62%
99%
Inspection readiness score
Regulatory file completeness and accessibility for FDA or GCP audits
Poor
Excellent
Overall CRO Attractiveness
Low priority
Passed over for new studies
Preferred partner
Offered studies first
Source: CROs now embrace data-driven site performance metrics to refine site selection. Protocol compliance, patient retention, and timely data submission consistently determine which sites get selected for repeat business and new studies. — SFCRI / CRO Selection Research 2024

Why This Matters to Sponsors and CROs

Sponsors Do Not Pick Sites.
They Pick Machines That Enroll On Time.

Every sponsor running a Phase 2 or Phase 3 trial is operating under one constraint: time. A delayed trial is not just an inconvenience. It is a direct financial loss. Sponsors pay $55,716 per day for a Phase III trial. Every day a site underperforms on enrollment or compliance costs real money — and the sponsor knows exactly which sites are causing it.

⏱️
Enrollment Speed
86% of trials miss enrollment targets on time. A site that consistently hits milestones gets selected first for future studies and gets offered higher-value protocols. A slow site gets cut mid-trial or dropped from the next one.
📋
Protocol Compliance
Protocol deviations trigger FDA observations and force sponsors to spend money on corrective action. Sites with high deviation rates cost sponsors more per enrolled patient than sites with clean records. CROs track this and sites with poor compliance simply do not get offered new studies.
🗂️
Inspection Readiness
FDA audits happen without warning. A site with automated document management and a clean regulatory binder passes inspection quickly. A site with paper records and manual filing creates findings that can halt enrollment and jeopardize the entire trial submission.
The compound effect
A site that enrolls fast, maintains compliance, and is always inspection-ready does not just survive in the current trial. It gets offered the next study before competitors are even approached. Over time, high-performing sites command better per-patient rates, get access to higher-value therapeutic areas, and become preferred partners across multiple sponsors simultaneously. Automation is how you get there without burning out your team.
GCP Compliance Automation

Automated Compliance Is Not Optional.
It Is What Keeps Your Site in Business.

Good Clinical Practice compliance is the regulatory baseline every clinical research site must maintain. Most sites manage it manually — paper binders, coordinator checklists, last-minute document scrambles before a monitor visit. We automate the entire compliance documentation layer.

Manual Compliance — What Goes Wrong
Expired delegation logs — coordinator delegations not updated when staff changes, caught in monitor visit, site gets a finding
Missing adverse event timestamps — AE reported 6 days late, protocol requires 24-hour reporting, protocol deviation logged
Unsigned consent forms — patient enrolled without fully executed ICF, requires protocol deviation report and may require patient withdrawal
Late data entry — visit data entered 12 days after the visit, CRO queries pile up, coordinator spends 3 hours resolving what should have been automatic
Automated Compliance — What We Build
Delegation log auto-alerts — GHL triggers a task and SMS to the PI when any staff credential expires or a role changes. Binder stays current automatically.
AE intake via SMS + Twilio — patient reports a symptom by text, Claude AI captures the structured AE data and timestamps it. Auto-filed in Supabase within minutes of the event.
eConsent workflow in GHL — consent form sent, signed, and timestamped before the patient is enrolled. No coordinator can advance a patient without a completed ICF on record.
Visit data auto-push to Sheets — post-visit data entered via a structured GHL form and pushed to Google Sheets and Supabase same day. CRO query rate drops to near zero.
GCP compliance is not a checklist. It is a live operational state. Automation keeps it that way without coordinator effort.
ICH E6(R3) aligned FDA 21 CFR Part 11 ready

Live Operations Dashboard

What Your Site Looks Like
to a CRO Monitor After Automation

This is a simulated view of a clinical research site running full AI operations automation. Every data point is automatically updated. No coordinator manually entered any of this.

Elite Clinical Network — Site Operations Dashboard
Live Data Auto-updated · Last sync 2 min ago
Active Studies
6
↑ 2 new this quarter
Patients Enrolled MTD
43
↑ 18% above target
Open Queries
2
↓ from 19 last month
Avg Query Response
0.9d
↓ from 4.7 days
GLP-1 Obesity Phase 3
Endocrinology · 40 patient target
35 / 40 enrolled
Rheumatoid Arthritis Phase 3
Immunology · 30 patient target
19 / 30 enrolled
Type 2 Diabetes CVOT
Cardiology / Endocrinology · 50 patient target
22 / 50 enrolled
Parkinson's Disease Phase 2
Neurology · 20 patient target
11 / 20 enrolled
Visit 3 — Vitals timestamp missing · Patient: MDR-0041 · GLP-1 Study
AI Draft Ready
Concomitant medication update — Patient: RA-0027 · RA Phase 3 Study
Coordinator Review
Weekly Enrollment Update — GLP-1 Obesity Study
Auto-generated · Ready to send
Monthly Safety Summary — RA Phase 3
Auto-generated · Ready to send
Screen Failure Log — T2D CVOT · Week 18
Auto-generated · Ready to send

Josh Leavitt
From Our Founder
"Clinical research sites are bleeding margin on tasks that a well-built automation system handles in milliseconds. Every hour a coordinator spends chasing a document or drafting a status email is an hour not spent on the work that actually moves a trial forward. When we build these systems for a site, two things happen immediately: overhead drops and CRO selection rates climb. Those are not separate outcomes. They are the same outcome — a site that runs like a machine attracts the studies that pay like one."
Josh Leavitt
Founder, Omni Online Strategies
Ready to Automate Your Site Operations

Cut Overhead. Win More Studies.
Run a Leaner Site.

We build and manage the full AI operations automation stack for your clinical research site or SMO network. Patient qualification via SMS, appointment booking, data tracking, and sponsor reporting — all automated. First workflow live in under 2 weeks.

Disclaimer

This is an interactive demonstration only. All company names, patient data, study names, dashboard figures, and performance metrics shown are fictional and for illustrative purposes only. No numbers presented in this demo constitute a promise, guarantee, or projection of results. Actual savings, efficiency gains, and CRO selection outcomes depend on site size, therapeutic area, protocol complexity, existing infrastructure, and operational maturity. Statistics cited are sourced from Jeeva Trials, Tufts Center for the Study of Drug Development (CSDD), ClinicalTrialPodcast.com, IntuitionLabs, ClinicalTrials.gov, and PMC 2024. Omni Online Strategies builds and delivers automation infrastructure — operational outcomes depend on the site's implementation, team adoption, and clinical operations.