FDA-defensible answers from your trial data.
In 30 seconds, not three days. Plain-language questions, answers that show their work.
Your regulatory answers are buried across datasets, SAPs, study reports, and thousands of papers.
AI tools promise to help. But traceability alone does not defend a result to a reviewer. The burden of proof remains.
THREE PILLARS
Three things
no other tool combines
Verification Beyond Traceability
Traceability shows where a number came from. Arclio proves it correct and unaltered — deterministic computations anyone re-runs to the same result, on a tamper-evident chain back to your data. Reviewers verify it themselves, no trust required.
Verification Beyond Traceability
Traceability shows where a number came from. Arclio proves it correct and unaltered — deterministic computations anyone re-runs to the same result, on a tamper-evident chain back to your data. Reviewers verify it themselves, no trust required.
Deploys on Your Infrastructure
Arclio's agent runs entirely inside your own infrastructure, so no data ever moves. Role-based access, encryption, and audit logging aligned to CDISC and SDTM keep your compliance posture preserved by design — never retrofitted afterward.
Deploys on Your Infrastructure
Arclio's agent runs entirely inside your own infrastructure, so no data ever moves. Role-based access, encryption, and audit logging aligned to CDISC and SDTM keep your compliance posture preserved by design — never retrofitted afterward.
Designed for Clinical Trial Data
Ask in plain English; get back tables and publication-grade charts — Kaplan-Meier plots with log-rank statistics, confidence bands, and cohort or subpopulation cuts. No SQL to write, no analyst to wait on, no delay.
Designed for Clinical Trial Data
Ask in plain English; get back tables and publication-grade charts — Kaplan-Meier plots with log-rank statistics, confidence bands, and cohort or subpopulation cuts. No SQL to write, no analyst to wait on, no delay.
SERVICES
What It Means for Your Business
Less waiting. More deciding.
Cost Management
Payment reminder
Onboarding
Social Media Campaign
Submission-ready
Ask your last-minute question on the way in. Answer before you sit down.
Cost Management
Payment reminder
Onboarding
Social Media Campaign
Submission-ready
Ask your last-minute question on the way in. Answer before you sit down.
Unlimited follow-ups
No statistician queue, no tickets, no analyst to interrupt.
Unlimited follow-ups
No statistician queue, no tickets, no analyst to interrupt.
Daily Tasks
Automate
Manual data entry
Report reformatting
Status follow-ups
Early signals
Safety flags, efficacy trends, subpopulation effects — one question away.
Daily Tasks
Automate
Manual data entry
Report reformatting
Status follow-ups
Early signals
Safety flags, efficacy trends, subpopulation effects — one question away.
Daily Tasks
Automate
Manual data entry
Report reformatting
Status follow-ups
Early signals
Safety flags, efficacy trends, subpopulation effects — one question away.
Code
1
2
3
4
5
Publication-grade charts
Kaplan-Meier curves, waterfall distributions, cohort comparisons — built from your data, ready to export.
Code
1
2
3
4
5
Publication-grade charts
Kaplan-Meier curves, waterfall distributions, cohort comparisons — built from your data, ready to export.
Code
1
2
3
4
5
Publication-grade charts
Kaplan-Meier curves, waterfall distributions, cohort comparisons — built from your data, ready to export.
Answers in 30 seconds
Ask in plain English. The agent runs the query and the math.
Answers in 30 seconds
Ask in plain English. The agent runs the query and the math.
Answers in 30 seconds
Ask in plain English. The agent runs the query and the math.
FEATURES
Features You Need
Everything your regulated organization requires — built in.
Zero Data Movement
The agent runs inside your environment through structured queries you can inspect.
Zero Data Movement
The agent runs inside your environment through structured queries you can inspect.
Natural Language Querying
Regulatory, clinical, and biostatistics teams ask in plain English. No SQL, no schema knowledge, no analyst.
Instant Visualization
Answers arrive as tables and charts — Kaplan-Meier plots with log-rank statistics, and exportable medians.
Independently Verifiable
Deterministic, re-runnable computations on a tamper-evident evidence chain.
FDA Readiness Scoring
A scorecard across efficacy, safety, data quality, competitive positioning, and biomarkers, with gap detection.
Built for Regulated Data
Role-based access, encryption, audit logging, and data handling aligned to CDISC and SDTM expectation
One system. Three layers of depth.
Start with a question. Scale into a full clinical-evidence platform.
LAYER 1
LAYER 2
LAYER 3
01
Connect your evidence
Load patient-level datasets, statistical analysis plans, clinical study reports, and the literature you rely on. Arclio structures it for query and analysis and keeps it inside your environment.
LAYER 1
LAYER 2
LAYER 3
01
Connect your evidence
Load patient-level datasets, statistical analysis plans, clinical study reports, and the literature you rely on. Arclio structures it for query and analysis and keeps it inside your environment.
OUR CLIENTS
Real Results From Real Teams
See how companies reduced errors and ran smarter with Arclio.
Cellectar Biosciences: A Clinical-Evidence Platform in Production
Cellectar runs Arclio in production on a late-phase oncology radiopharmaceutical program — natural-language access to trial data, on-demand efficacy and safety analysis, side-by-side comparison against published literature, and FDA readiness reporting where every figure links back to its source.
%
decrease in operational time
%
increase in literature retrieval speed
Medo: From Wellness App to Intelligent Health Companion
Medo transformed from a simple wellness tool into a real-time, personalized health companion—boosting speed, scalability, and user experience.
%
growth in sales
%
rise in engagement
Village Health Works: AI-Powered Donor Engagement That Drives Impact
Village Health Works strengthened its digital presence, donor engagement, and fundraising outcomes through AI-enhanced marketing and campaign optimization.
%
gain in retention
%
surge in profits
Cellectar Biosciences: A Clinical-Evidence Platform in Production
Cellectar runs Arclio in production on a late-phase oncology radiopharmaceutical program — natural-language access to trial data, on-demand efficacy and safety analysis, side-by-side comparison against published literature, and FDA readiness reporting where every figure links back to its source.
%
decrease in operational time
%
increase in literature retrieval speed
Medo: From Wellness App to Intelligent Health Companion
Medo transformed from a simple wellness tool into a real-time, personalized health companion—boosting speed, scalability, and user experience.
%
growth in sales
%
rise in engagement
Village Health Works: AI-Powered Donor Engagement That Drives Impact
Village Health Works strengthened its digital presence, donor engagement, and fundraising outcomes through AI-enhanced marketing and campaign optimization.
%
gain in retention
%
surge in profits
Cellectar Biosciences: A Clinical-Evidence Platform in Production
Cellectar runs Arclio in production on a late-phase oncology radiopharmaceutical program — natural-language access to trial data, on-demand efficacy and safety analysis, side-by-side comparison against published literature, and FDA readiness reporting where every figure links back to its source.
%
decrease in operational time
%
increase in literature retrieval speed
Medo: From Wellness App to Intelligent Health Companion
Medo transformed from a simple wellness tool into a real-time, personalized health companion—boosting speed, scalability, and user experience.
%
growth in sales
%
rise in engagement
Village Health Works: AI-Powered Donor Engagement That Drives Impact
Village Health Works strengthened its digital presence, donor engagement, and fundraising outcomes through AI-enhanced marketing and campaign optimization.
%
gain in retention
%
surge in profits
INTEGRATIONS
One Layer.
Endless Use Cases.
Connect the evidence you already have.
REVIEWS
Trusted by Visionaries
Trusted by Visionaries
Hear from real users who achieved success with our automation
Dan Kashman
Medo
"We had ambitious goals but no clear path to get there. Arclio gave us a structured process that built the right foundation — and then delivered on it."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues are now a non-issue."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues are now a non-issue."
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a copuple of minutes — and we're catching patterns in clinical data we would have missed before.”
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a copuple of minutes — and we're catching patterns in clinical data we would have missed before.”
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
REVIEWS
Trusted by Visionaries
Trusted by Visionaries
Hear from real users who achieved success with our automation
Dan Kashman
Medo
"We had ambitious goals but no clear path to get there. Arclio gave us a structured process that built the right foundation — and then delivered on it."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues are now a non-issue."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues are now a non-issue."
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a copuple of minutes — and we're catching patterns in clinical data we would have missed before.”
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a copuple of minutes — and we're catching patterns in clinical data we would have missed before.”
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
REVIEWS
Trusted by Visionaries
Trusted by Visionaries
Hear from teams who put their evidence to work with Arclio.
Dan Kashman
Medo
"We had ambitious goals but no clear path to get there. Arclio gave us a structured process that built the right foundation — and then delivered on it."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues."
David Stern
Stern
"Our system was producing errors no amount of manual tuning could fix. Arclio brought in AI that solved what we couldn't — accuracy issues."
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a couple of minutes — and we're catching patterns in clinical data we would have missed before.”
Jarrod Longcor
Cellectar
“What used to take our analysts a full day now takes a couple of minutes — and we're catching patterns in clinical data we would have missed before.”
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Tim Miner
By The People Technology
"After several projects working together, Arclio keeps saying yes to problems other teams wouldn't touch. They think with us, not just for us."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Michael Goldrich
Vivander
"Arclio digs into the actual problem, not just the spec — that's why our joint projects have some of the highest retention rates in our portfolio."
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
Rosemary Ortlieb
Village Health Works
“Coordinating across continents meant delays whenever priorities shifted. Arclio automated how we adapt — now it takes hours, not days.”
PRICING
Investment
Statistician-generated regulatory outputs run into six figures per study and take weeks.
Arclio is in active validation against completed studies to produce comparable, CDISC-conformant outputs in a fraction of the time and cost.
Outputs go through validation and your quality process before they support a submission.
Arclio engagements start at $30,000 per year.
FAQ'S
Frequently Asked Questions
Find quick answers to the most common support questions
Still Have Questions?
Feel free to get in touch with us today!
Does our data ever leave our environment?
No. Arclio runs inside your infrastructure. The agent reaches your data through structured queries you can inspect; the data itself does not move to us.
How is "verified" different from "traceable"?
Traceability shows where a number came from. Verification proves it is correct and unaltered. Arclio's computations are deterministic, so anyone can re-run them and get the identical result, and the evidence chain is tamper-evident, so any change to the record shows. A reviewer can confirm a result themselves rather than taking your word for it.
What data sources can Arclio connect to?
Patient-level datasets, statistical analysis plans, clinical study reports, and the literature you rely on — competitor studies, prior trials, and the public FDA record. Data handling is aligned to CDISC and SDTM expectations.
What does Arclio produce?
Tables and publication-grade charts, including Kaplan-Meier plots with log-rank statistics, confidence bands, and exportable medians; literature-versus-data comparisons; and an FDA readiness scorecard across efficacy, safety, data quality, competitive positioning, and biomarkers.
Who is it for, and do we need technical users?
Clinical-stage and commercial biopharma with lean regulatory and biostatistics teams. Team members work in plain language — no SQL, schema knowledge, or analyst required. We started in oncology and extend to any therapeutic area with structured trial data and a regulatory bar to clear.
FAQ'S
Frequently Asked Questions
Find quick answers to the most common support questions
Still Have Questions?
Feel free to get in touch with us today!
Does our data ever leave our environment?
No. Arclio runs inside your infrastructure. The agent reaches your data through structured queries you can inspect; the data itself does not move to us.
How is "verified" different from "traceable"?
Traceability shows where a number came from. Verification proves it is correct and unaltered. Arclio's computations are deterministic, so anyone can re-run them and get the identical result, and the evidence chain is tamper-evident, so any change to the record shows. A reviewer can confirm a result themselves rather than taking your word for it.
What data sources can Arclio connect to?
Patient-level datasets, statistical analysis plans, clinical study reports, and the literature you rely on — competitor studies, prior trials, and the public FDA record. Data handling is aligned to CDISC and SDTM expectations.
What does Arclio produce?
Tables and publication-grade charts, including Kaplan-Meier plots with log-rank statistics, confidence bands, and exportable medians; literature-versus-data comparisons; and an FDA readiness scorecard across efficacy, safety, data quality, competitive positioning, and biomarkers.
Who is it for, and do we need technical users?
Clinical-stage and commercial biopharma with lean regulatory and biostatistics teams. Team members work in plain language — no SQL, schema knowledge, or analyst required. We started in oncology and extend to any therapeutic area with structured trial data and a regulatory bar to clear.
FAQ'S
Frequently Asked Questions
Find quick answers to the most common support questions
Still Have Questions?
Feel free to get in touch with us today!
Does our data ever leave our environment?
How is "verified" different from "traceable"?
What data sources can Arclio connect to?
What does Arclio produce?
Who is it for, and do we need technical users?
COMPARISON
Why Choose Us Over Others
See how we compare against others in performance
Ask in plain English, get real answers
Every answer re-runs to the same result
Runs in your environment; nothing moves
Kaplan-Meier, log-rank, and cohort charts
FDA readiness scoring and gap detection
Everything else
Needs a biostatistician and a long queue
Traceability only, then trust the black box
Your data uploads to third-party servers
Static dashboards built on stale exports
No regulatory lens or FDA readiness check