The Intelligent Operating System for clinical trials
Know where your trial's risks are before they become findings
Your team shouldn’t have to search for problems in the data. TRI turns scattered study data into clear, prioritized actions, so you catch risk sooner, decide faster, and walk into every inspection with confidence.
AI-driven RBQM for clinical trials
Know where your trial's risks are, before they become findings.
Your team shouldn’t have to search for problems in the data. TRI turns scattered study data into clear, prioritized actions, so you catch risk sooner, decide faster, and walk into every inspection with confidence.
The problem
Oversight shouldn't feel like guesswork.
Your study’s story is scattered across capture systems, spreadsheets, dashboards, email, and someone’s head. Risk surfaces in a review weeks after it started. And when an inspector asks you to prove your oversight, you’re reconstructing it from memory.
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Plan
Risk Planning Starts on the Back Foot
Risk assessments take days of expert time to build from the protocol, then sit in a document while the study moves on.
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Monitor
Always One Step Behind
Site and patient issues surface after they've already cost you time, quality, and budget.
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Prove
Can You Prove It?
When the finding lands on your name, memory isn't evidence. You need a clear, defensible trail.
The problem isn't data volume. It's decision-making.
The difference
Without RBQM. Traditional RBQM. Intelligent RBQM.
The same trial, three ways to run it, and what earlier, intelligent oversight gives you back.
Protocol risk assessment
Risk detection
Monitoring effort & cost
Oversight evidence
Inspection readiness
What we offer
One RBQM platform. Four ways to take control.
Start with the problem in front of you today. Add capability when you’re ready.
OPRA Centralized Monitoring
Cut through the complexity.
Focus on the critical signals across every site and stay ahead of risk, with confident, data-driven decisions instead of a sea of dashboards.
OPRA Risk Assessment & Management
Design quality in from the start.
Build, track and prove your risk strategy in one place. Every score, mitigation and change traceable to a name, a date and a reason.
OPRA Subject Monitoring
One clinical timeline per subject.
See what changed since your last review, compare subjects easily, and back every judgment with a built-in audit trail and role-based access.
TRIAL.OS
The AI operating system.
Guided actions that tell your team where to act, ranked and explained, so you move from a sea of alerts to a clear next step. Working above the systems you already run.
How it all works together
One connected RBQM workflow. One intelligent layer.
Risk Assessment, Centralized Monitoring and Subject Monitoring run as a single continuous cycle: plan, detect, review. TRIAL.OS adds an AI layer to each, so every stage gets faster and sharper.
RiskIQ
AI-drafts CtQs, risks and controls from your protocol in minutes.
Risk Assessment &
Management
Assess protocol risk, define your CtQs, KRIs and controls, and build the risk plan.
Predict & Explain
Flags risk before it materializes and explains each signal, ranked, in plain language.
Centralized Monitoring
Monitor KRIs across every site, surface signals and trends, and drill from study to site to subject.
Guided Review
Surfaces what changed since your last review, in context, so review is faster.
Subject Monitoring
Review one clinical timeline per subject, compare subjects, and back every judgment with an audit trail.
RiskIQ
AI-drafts CtQs, risks and controls from your protocol in minutes.
Risk Assessment & Management
Assess protocol risk, define your CtQs, KRIs and controls, and build the risk plan.
Predict & Explain
Flags risk before it materializes and explains each signal, ranked, in plain language.
Centralized Monitoring
Monitor KRIs across every site, surface signals and trends, and drill from study to site to subject.
Guided Review
Surfaces what changed since your last review, in context, so review is faster.
Subject Monitoring
Review one clinical timeline per subject, compare subjects, and back every judgment with an audit trail.
Built around the way you actually work
Your role. Your risk. Your Monday morning.
RBQM isn’t one story told four ways. It’s different problems, each taken seriously.
OPRA Centralized Monitoring
The finding lands on your name.
Get demonstrable, consistent oversight across every CRO relationship, and walk into inspections with confidence rather than a scramble for evidence.
CROs
RBQM is in every RFP now.
Win with evidence, not adjectives. Differentiate your delivery with a platform your teams can stand behind in the room and answer hard questions with.
Medical & Central Monitors
Your judgment deserves better than a spreadsheet.
One clinical timeline per subject, changes surfaced since your last review, signals in context, so experience meets the full picture, fast.
Trial Managers
Stop chasing scattered data.
See what’s coming across your whole study and know where to point your team first, without living in spreadsheets and status calls.
Built around the way you actually work
Your role. Your risk. Your Monday morning.
RBQM isn’t one story told four ways. It’s different problems, each taken seriously.
OPRA Centralized Monitoring
The finding lands on your name.
Get demonstrable, consistent oversight across every CRO relationship, and walk into inspections with confidence rather than a scramble for evidence.
CROS
RBQM is in every RFP now.
Win with evidence, not adjectives. Differentiate your delivery with a platform your teams can stand behind in the room and answer hard questions with.
Medical & Central Monitors
Your judgment deserves better than a spreadsheet.
One clinical timeline per subject, changes surfaced since your last review, signals in context, so experience meets the full picture, fast.
Trial Managers
Stop chasing scattered data.
See what’s coming across your whole study and know where to point your team first, without living in spreadsheets and status calls.
How it all works together
One connected RBQM workflow. One intelligent layer.
Risk Assessment, Centralized Monitoring and Subject Monitoring run as a single continuous cycle: plan, detect, review. TRIAL.OS adds an AI layer to each, so every stage gets faster and sharper.
Its all we do
run on OPRA
time back to your team
from a sponsor or CRO
See it run
RBQM is becoming AI-driven. Which side of the gap are you on?
A small group of early adopters are quietly changing the game. By augmenting RBQM with AI, they’re compressing operational cycle times, turning raw signals into prioritized, intelligent actions, and predicting risk before it materializes. An edge that wasn’t even imaginable when ICH E6 (R3) came into force. The gap is widening.
TRI e-Learning
Build RBQM fluency across your team.
CPD-accredited courses in Good Clinical Practice, ICH E8 (R1) and Risk Assessment and Controls, so your people grow alongside the platform.
RBQM success stories
Trusted where the stakes are highest
TRI’s best-in-class technology lets us proactively identify and manage risks, improving quality and patient safety.
Peter Benton
President & CEO, Worldwide
150 clinical trials now run in TRI’s RBQM platform, improving data quality, trial efficiency and patient safety.
Amandeep Sonik
Senior Director, RBQM, Worldwide
What truly set TRI apart was their unparalleled commitment to a quality deliverable.
Jeff Smith
Former CEO, Alimentiv
Trusted by leading sponsors and CROs worldwide
Worldwide
IQVIA
Roche
Emmes
Caidya
Alimentiv
Klifo
Advanced Clinical
Ready when you are
See our solutions on your own trial.
Book a demo, or send us a protocol and we’ll show you what earlier, provable oversight looks like. Nothing to install. No project to approve.
Not ready to talk? Calculate your savings first.
Why do Sponsors and CROs choose TRI for AI-driven RBQM?
Ask your favorite AI assistant how our solutions support risk-based quality management in clinical trials.
Explore key information about TRI
Questions, answered head-on
Choosing an oversight partner takes precision and clarity. Here are the questions we hear most.
How does your system meet ICH E6 (R3)?
OPRA supports all key RBQM processes defined in ICH E6 (R3) and earlier guidelines, so sponsors and CROs can manage quality and risk across the whole trial lifecycle. We work closely with ACRO, PHUSE and TransCelerate, and apply best practice in every platform update.
What risk indicators do you support, and can we customize them?
The system supports any number and type of KRIs, KPIs and QTLs. We give you a standard set to start with, and you can customize it by study or therapy area, or create new charts and indicators as needed.
Can users drill down from study to site, subject and visit level?
Yes. Each KRI or KPI on the Study Hub clicks through to more detailed data, filtered to subjects, visits, assessments or specific data points. That drill-down is core to strong centralized monitoring.
What support do you provide for onboarding and training?
Every client gets a full implementation team, setup templates, a sandbox to test configurations, and a walkthrough of your custom setup. We train your admins and super users, with online training available before and after launch.
How long have you provided centralized monitoring?
TRI has delivered clinical trial tools since 2013. We launched Centralized Monitoring in 2016 and added Risk Assessment and Management in 2020. Around 30% of our work has been in oncology.
TRI insights & news
Keep reading
Practical thinking on RBQM, oversight and inspections.
Beyond Spreadsheets: A Smarter Approach to Subject Monitoring
Why Leading Sponsors and CROs Are Moving to Intelligent, Faster Monitoring. We’ll discuss:
RBQM: Risked-Based Everything. Except the CRA
RBQM has transformed clinical trial oversight, but the CRA role has been left behind. In this free 30-minute live webinar, we set out a practical vision for what genuine risk-based monitoring looks like in practice.
Mastering Audit Trail Review Under ICH E6(R3)
We’re excited to welcome guest speaker, Nechama Katan, recognized expert in RBQM architecture and audit trail analytics, who will be discussing: