THE INTELLIGENCE LAYER FOR CLINICAL TRIALS
What if your data could talk?
Your data already knows where the problems are. Imagine it could tell you, early, in plain language, so your team can act.
The future of clinical trials isn’t more software. Its better decisions
TODAY’S REALITY
Clinical trials have become too complex to hold inside your head.
Your study’s story is spread across capture systems, warehouses, spreadsheets, dashboards, email, and someone’s head. Nobody’s doing anything wrong. It’s just fragmented. So how do you know where to focus?
Where your study's data lives
systems
warehouses
reviews
How it feels
Your study’s story is spread across capture systems, warehouses, spreadsheets, dashboards, email, and someone’s head. Nobody’s doing anything wrong. It’s just fragmented. So how do you know where to focus?
The problem isn’t data volume – it’s decision making. TRIAL.OS is the intelligence layer for modern clinical trials: combining TRI’s deep RBQM expertise with data science and AI, it’s built to turn complex study information into earlier insight, clearer priorities and better decisions – so teams know what matters, see what’s coming, and know what to do next.
TRIAL.OS works above the systems you already run. Nothing to replace. Nothing to install.
THE TRIAL.OS CAPABILITIES
From information to intelligence
Some of this you can use today. The rest we’re building in the open, and we’ll always be candid about which is which. Ask us what’s live this month.
Understand
Predict
Explain
Recommend
Automate
Learn
Bring more certainty to every trial.
TrialOS connects trial planning, governance and operational intelligence in one platform, helping teams move faster with greater visibility and control.
SEE IT RUN
Protocol in. Intelligence out.
Watch a protocol become structured intelligence of CtQs, risks and controls in Protocol Insights – Risk IQ
PROTOCOL INSIGHTS – THE FIRST TRIAL.OS APP FAMILY
Real problems. Real Al applications.
Every application starts with an actual problem to solve.
Protocolinsights
RiskiQ
A structured first draft of CtQs, risks and controls in minutes, each traced to the protocol section it came from. Your team review and action the output.
Protocolinsights
Complexity
Understand the complexity of your design from the perspective of the site, the subject and the caregiver, in minutes.
Protocolinsights
Feasibility
A rapid assessment of the impact of inclusion and exclusion criteria and competing trials, with guidance on how to improve the feasibility of the protocol.
GUIDED ACTIONS
Imagine Monday morning.
Instead of a sea of alerts, and dashboards with more colours than a rainbow… your data tells you where to action.
Ranked.
Explained.
Ready.
We call this Guided Actions.
BUILT AROUND THE WAY YOU ACTUALLY WORK
Your role. Your risk. Your Monday morning.
TRIAL.OS isn’t one story told six ways – it’s six different problems, each taken seriously.
CLINICAL OPERATIONS & SPONSORS
"You're accountable - even when they're responsible."
Vendor oversight that looks fine until it’s actually tested is the finding that lands on your name. Demonstrable, consistent oversight across every CRO relationship – and confidence walking into an inspection.
See oversight you can prove →
MEDICAL & CENTRAL MONITORS
"Your judgement deserves somewhere better to land than a spreadsheet."
Experience is irreplaceable – but nobody can hold dozens of subjects’ timelines in their head at once. One clinical timeline per subject, changes surfaced since your last review, signals in context.
See subject review, rebuilt →
RISK, QUALITY & COMPLIANCE
"Not 'did I miss a risk' - 'can I prove l didn't?'"
A risk register is only as good as the person maintaining it – and people move on. Every score, mitigation and change traceable to a name, a date and a reason, no matter who’s on the team today.
See subject review, rebuilt →
CROS
"RBQM is in every RFP now. Answer with evidence, not adjectives."
Your sponsors are asking harder questions about oversight and intelligence in every bid. Differentiate your delivery with a platform your teams can stand behind in the room.
See the CRO partnership →
Ready to run trials with greater control?
See how TrialOS brings your trial operations, governance and intelligence together in one connected platform.
From Idea to Production
Good ideas don't all start with us.
Thirteen years of RBQM drive our roadmap. Your idea takes the same road to production as ours.
Door One. Our Roadmap
Thirteen years of RBQM.
Industry research, client feedback, and everything 450+ trials taught us.
Door Two. Your Idea
Where your systems stop.
Brought to us by the people who need it. Prototyped fast, not queued for a distant roadmap.
01
Prototype
built in weeks
not months / years / never
02
Client + Market Value Confirmation
Proven with clients, not just by us.
03
Production
Validated SDLC
GCP compliant
21 CFR Part 11
Audit ready
Governed by Design
Intelligence you can answer for.
Every AI capability ships inside a governance framework — because in a regulated trial, “trust us” isn’t an answer.
Human in the loop
A requirement of the EU AI Act — and of ours. AI drafts and suggests; your team decides. Some decisions AI never touches.
Every action logged
Anything AI does is recorded with its rationale and timestamp — an audit trail an inspector can actually follow.
Your documents, governed
Clear, written answers on where your documents go, who can see them, and how they're handled — before you're asked to share anything.
Closed-Loop Learning
Every study makes the next one smarter.
Intelligence that improves with every study you run — and everything it learns belongs to you.
What it learns from your studies stays yours. Never pooled. Never shared.
Closed-loop learning. The vision of TRIAL.OS.
For Every Trial
Start Small. Start Now. Nothing To Replace.
Flexible
Choose the app that solves today's problem. Add more only when required. One app, one protocol, one study is a fine place to start.
Affordable
Pay for what you use — not a platform-sized commitment. Priced so a small sponsor can say yes.
Modern Subscription
Buy it like modern software. Start in days, scale when you're ready, step back when you're not. No multi-year lock-in. We host everything.
BUILT AROUND THE WAY RBQM ACTUALLY WORKS
We're not a start-up.
We didn’t start with Al and go looking for a clinical problem. We started with thirteen years of RBQM.
the intelligence is built on it
run on OPRA
have worked at a sponsor and/or CRO
TRIAL.OS FOR EVERY TRIAL
Start small. Start now. Nothing to replace.
The same intelligence, within reach of every trial: a top-ten pharma with a global portfolio, or a biotech taking its first compound into Phase 1.
Flexible
Choose the app that solves today’s problem. Add more only when required. Nothing to replace.
Affordable
Pay for what you use. Not a platform-sized commitment. We understand study budgets can be tight.
Modern subscription
Modern SaaS; we host everything. Start in days, scale when you’re ready, step back when you’re not. No multi-year lock-in.
TRIAL.OS FOR EVERY TRIAL
Start small. Start now. Nothing to replace.
The same intelligence, within reach of every trial: a top-ten pharma with a global portfolio, or a biotech taking its first compound into Phase 1.
Flexible
Choose the app that solves today’s problem. Add more only when required. Nothing to replace.
Affordable
Pay for what you use. Not a platform-sized commitment. We understand study budgets can be tight.
Modern subscription
Modern SaaS; we host everything. Start in days, scale when you’re ready, step back when you’re not. No multi-year lock-in.
WHAT IF YOUR DATA COULD TALK?
Find out. Send us a protocol.
Protocol in. Intelligence out. Nothing to replace. Nothing to install. No project to approve.
Rather not share yours yet? We keep a library of synthetic protocols by therapy area. Watch It run on one of ours.
BEFORE YOU ASK
The questions clinical teams ask US
Straight answers on validation, control, data and cost.
Is this just a prototype?
No. TRIAL.OS is built under the same Quality Management System as OPRA: ICH E6 (R3), 21 CFR Part 11, GCP and GDPR. Anyone can build an impressive demo in days; validated, audit-ready technology is a different job. When we show you a prototype, we label it as one.
Does the AI make decisions on its own?
No. TRIAL.OS is designed to support people, not replace them. It can surface information, identify patterns and recommend next actions, but your team remains in control of the decisions that matter.
What happens to our data?
Your data stays protected and governed. TRIAL.OS is designed around secure, controlled access, with clear oversight of how information is used. Your organisation’s data is not treated as an open training set.
Do we have to replace our systems?
No. TRIAL.OS is designed to integrate with what you already have. You can start with a single study, team or use case and add capability over time, without a large-scale system replacement.
What’s actually live today?
TRIAL.OS is being built as a working platform, not a future concept. Core capabilities can be deployed today, while new functionality continues to be developed, tested and validated before it is introduced into live trial workflows.
What if your data could talk?
Find out. Send us a protocol.
Protocol in. Intelligence out
Nothing to replace. Nothing to install. No project to approve
COMING SOON
Try it yourself – the TRIAL.OS App Store
Rather not share yours yet? We keep a library of synthetic protocols by therapy area – watch it run on one of ours, matched to your world