Part of Trial360 OS — The Clinical Trial Operating System

The site operations
platform built for
clinical research.

Site360 gives CRCs, PIs, and site coordinators everything they need to run an inspection-ready site — from ISF management to participant enrollment, safety reporting, and monitoring visit preparation.

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ICH E6(R3)21 CFR Part 11DIA TMF Reference ModelISO 14155
Site Health
Complete Visibility
Risk Intelligence
Real-Time Status
ISF Filing
Inspection Ready
Site360
★ AI Copilot

Ask Anything.
Get Intelligent
Answers.

Your AI site assistant understands your study, your documents, and your workflows.

✓Natural language interaction
✓Context-aware responses
✓Actionable insights
✓Always learning, always accurate
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Site360 AI Copilot · MAY-001LIVE
|
Delegation Log Update
Staff & Delegation
OVERDUE
SAE Follow-up Report
Safety Reporting
OVERDUE
GCP Refresher Training
Staff & Delegation
EXPIRING
IP Temperature Log
IP & Supplies
MISSING
SIV Follow-up Documents
Monitoring Visits
MISSING
Ask anything about your site
Send
Try These Examples
What's outstanding before my monitoring visit?
Who is delegated for informed consent right now?
Show overdue safety reports for this site.
Draft a note to file for this deviation.
Which training records expire this month?
★ AI INSIGHT

Site MAY-001 has 5 outstanding items ahead of the Sep 23 visit. 2 are overdue. Inspection readiness risk is Medium.

Smarter Responses
AI understands your site context, not just keywords.
Actionable Insights
Go beyond answers. Get recommendations.
Inspection Ready
AI helps you stay inspection-ready at all times.
Continuously Learning
Improves with every interaction across your sites.
One Platform. Complete Site Control.

Everything You Need.
Powered by Intelligence.

Intelligent Filing
AI suggests ISF placement and flags potential misfiles automatically.
Real-Time Visibility
Track completeness, risk, and health across every site panel.
Smart Expectations
Knows what documents should exist based on trial phase and milestones.
Inspection Ready
Built-in dashboards keep your site prepared at all times.
Human-in-the-Loop
AI assists — your delegated staff always lead the way.
Secure & Compliant
21 CFR Part 11-ready controls and role-based access.

Built for Intelligence.
Designed for People.

AI That Works With You
Site360 understands your site context and helps your team make faster, smarter decisions across every task and document.
Complete Control
Manage every document, task, review, and safety event in one unified platform — no more scattered systems or manual tracking.
Proactive Risk Intelligence
Identify missing, overdue, expired, and high-risk items before they become findings — not during an inspection.
13 Panels. Every Site Operation.

Built for the CRC. Ready for the inspector.

Every panel in Site360 is designed around how site teams actually work — not how software engineers think they work.

Site Dashboard
Live Site Health Score, enrollment progress, deadlines, and action items — everything a CRC needs every morning.
Investigator Site File
Full ISF management aligned to DIA Reference Model. Site-scoped document control with TMF reconciliation.
Participant Management
Enroll participants, send login credentials, track consent status, and monitor diary compliance in real time.
Safety Reporting
AE/SAE log with severity tracking, protocol deviations, and CAPA management. Always inspection-ready.
Monitoring Visits
SIV, IMV, and COV scheduling with action item tracking and SDV readiness checklists.
Staff & Delegation
Delegation of Authority log, staff qualifications, GCP training records, and role management — all in one place.
IP & Supplies
Investigational product accountability, device inventory tracking, temperature logs, and expiry alerts.
Payments
Milestone-based payment tracking, invoice status, and financial visibility aligned to your site agreement.
Query Management
Route monitoring queries to the right staff, track SLA response times, and maintain a full audit trail.
Simple Setup

From activation to close-out.

01
Site setup
Your sponsor or CRO creates your site in Trial360 OS and assigns you access via a secure invitation link.
02
Configure your ISF
Upload your site documents, configure your delegation log, and connect your study instruments.
03
Enroll participants
Create participant accounts, send login credentials, and start collecting diary data from day one.
04
Stay inspection-ready
Your Site Health Score updates in real time. Every document, every action, every decision is audit-trailed.
Built for Site Teams
Designed by CRCs for CRCs. Every panel has a purpose rooted in real site operations.
Scalable for Every Site
From single-site studies to multi-site programs — Site360 grows without added complexity or cost.
Trusted & Reliable
Enterprise-grade security, validated processes, and a platform built on the same infrastructure as TMF360.
Designed to Support Compliance with Leading Regulatory Standards
ICH E6(R3) Aligned DIA TMF Reference Model 21 CFR Part 11 Ready Role-Based Access Full Audit Trail Data Security Inspection-Ready Exports
Who It's For

Every Role in Site Operations

CRCs
Day-to-day site operations, from ISF to enrollment.
Principal Investigators
Oversight visibility without the admin burden.
Sub-Investigators
Delegated task visibility and safety sign-off.
CRAs / Monitors
Visit prep, SDV readiness, and action item tracking.
Sponsors
Portfolio-level visibility across every site.
CROs
Multi-site management with complete oversight.
Regulatory Coordinators
IRB submissions and continuing review tracking.
IP & Pharmacy Staff
Investigational product accountability and chain of custody.
QA / Auditors
Read-only audit access with full traceability.
Site Directors
Real-time site health and staffing oversight.
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PANELS IN SITE360
0%
AVG. SITE HEALTH SCORE
< 0H
QUERY RESPONSE TIME
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Turn Your Site Into
Inspection-Ready Operations

Move beyond scattered spreadsheets. Site360 gives your team the visibility, control, and AI-powered insight to stay inspection-ready at every stage of the trial.

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