ClinicalOS

Early access

Protocol to clinical study report, on one platform.

ClinicalOS runs device clinical investigations end to end: protocol development, EDC, CTMS, eTMF, eConsent, ePRO, monitoring, database lock and validated statistical analysis. Purchasable on its own — no eQMS required.

Built for: Sponsors and clinical operations teams running device investigations

About this app

Take a device investigation from protocol to clinical study report while keeping patient data protected and audit-ready.

ClinicalOS supports clinical operations for device studies: patient data sheet import with automatic recognition of outcome scores such as ODI, NRS/VAS, age and gender; field mapping and validation; a free site portal for investigational sites; and de-identified transfer of finished cohorts for analysis.

What you can do

Import patient data sheets with guided field mapping and ambiguity resolution
Validate outcome measures and resolve recognition errors before committing data
Invite investigational sites into the free site portal and manage coordinators
De-identify and transfer cohorts for downstream evidence analysis

Problems it solves

Site spreadsheets and case report forms re-typed into study databases
Protected health information handled without HIPAA-grade safeguards
No auditable boundary between identifiable clinical data and analysis data sets

Who it is for

Clinical operations and study managers
Data managers and clinical data entry staff
Investigational site coordinators
Sponsors running device investigations

Works with

ClinicalOS captures and protects the patient data, StudyOS watches execution across sites, and EvidenceOS consolidates the de-identified result — one chain from data sheet to evidence, with the privacy boundary enforced by the platform.

EDC, CTMS and eTMF in one system instead of three integrations

Traceability from protocol requirement to eCRF field to analysis output

Statistics run on deterministic, versioned, reproducible code — never an LLM

Capabilities

What ClinicalOS does

Every module writes to the same controlled record set, so nothing has to be exported, re-keyed or reconciled.

Protocol Builder

Describe the study in plain language and get a structured draft protocol — objectives, endpoints, eligibility, schedule of events, safety definitions, statistics. Clinical and regulatory professionals review and approve before anything becomes real.

Protocol intelligence

Draft protocols are checked for inconsistent endpoints, contradictory eligibility criteria, undefined assessments, gaps in the visit schedule and missing statistical assumptions. Findings are recommendations, not conclusions.

Electronic data capture

Configurable eCRF designer with conditional logic, calculations, edit checks, queries, source verification status, autosave, visit and form locking, signatures and a complete audit trail.

CTMS

Study portfolio, site feasibility and qualification, startup and activation, contracts, enrollment tracking, milestones, monitoring visits, payments and site performance.

eTMF

Configurable filing structure, essential document metadata, version control, completeness and expiry monitoring, and inspection-ready exports.

eConsent and ePRO

Versioned electronic informed consent with reconsent handling, plus scheduled patient-reported outcome questionnaires with reminders on a mobile-first, multilingual interface.

Site portal

Coordinators land on exactly what needs action: subjects due, missing forms, open queries, overdue documents, expiring certifications. Minimal clicks, minimal training.

Validated statistical engine

Analyses run on deterministic, tested statistical code. Every result stores dataset version and checksum, database lock ID, code version and checksum, environment, analyst, reviewer and approval — so it is independently reproducible.

Regulatory foundation

Standards it is built against

21 CFR Part 11
21 CFR Parts 50, 54, 56, 812
ISO 14155
Good Clinical Practice
HIPAA-aligned PHI architecture

Qevatrix Intelligence

Where AI helps — and where it stops

ClinicalOS drafts protocols, SAPs, monitoring plans and narrative sections, and flags internal inconsistencies. It never performs regulated statistical calculations, locks a database, approves a protocol or signs a record.

AI output is always a draft. Approval, signature and release of any regulated record require an authenticated, qualified human.

Modules

ClinicalOS module by module

Every module has its own page with features, plan availability and pricing.

Electronic Data Capture (EDC)

Configurable eCRFs with edit checks, queries and full source-verification status.

CTMS — Clinical Trial Management

Sites, visits, monitoring and milestones from feasibility to close-out.

eTMF — Electronic Trial Master File

An expected-document structure that tells you what is missing before an inspector does.

Protocol Builder & SAP Builder

From plain-language study description to a structured draft protocol and statistical analysis plan.

eConsent & ePRO

Versioned electronic consent and scheduled patient-reported outcomes on a mobile-first interface.

Investigation Site Portal

Coordinators land on exactly what needs action — free for your investigational sites.

Clinical Data Import

Upload datasheets and let AI recognise ODI, age, VAS and other fields automatically.

Validated Statistical Engine

Deterministic, versioned, reproducible analysis — never an LLM.

Pricing

ClinicalOS plans

Protocol to clinical study report on one platform, priced per active study — so a first-in-human investigation does not need an enterprise clinical suite.

Edit/power users you need

Single Study

Sponsors running one active clinical investigation

$2,750/month

billed annually, per active study · $33,000 per year

Study team users included · up to 20 sites

Core AI drafting for protocol, SAP and narratives, fair use

EDC with edit checks and query management
CTMS for sites, visits and monitoring
eTMF with expected-document structure
Protocol Builder and SAP Builder
Validated, reproducible analysis foundation
Part 11-ready signatures and audit trail

Best for multi-study teams

Clinical Program

Teams running several studies in parallel

From$5,500/month

billed annually · $66,000 per year

Up to 3 active studies · larger site capacity

Higher AI allowance across studies, fair use

Everything in Single Study, for up to 3 active studies
eConsent and ePRO
Cross-study dashboards and enrolment tracking
Dedicated study configuration support
Programme-level document and training reuse

Enterprise

Sponsors with an ongoing clinical portfolio

Get A Quote

annual agreement

Custom study and site scale

Custom AI allowances and controls

Unlimited or custom study portfolio
Enterprise security and SSO
Validation services and reproducibility evidence
Integrations with safety, labs and imaging vendors
Dedicated support

Get A Quote

AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.

Add EvidenceOS

Sponsors who follow an investigation with post-market surveillance run EvidenceOS on the same platform, so clinical data and real-world evidence share one record set.

Explore EvidenceOS

Prices in USD, excluding applicable taxes. ClinicalOS is in early access: eConsent and ePRO are being rolled out with early-access sponsors and are not advertised as generally available. Self-service checkout is not enabled — every engagement starts with a demo and scoping call.

Compare

What is in each plan

ClinicalOS plan feature comparison
Capability	Single Study	Clinical Program	Enterprise
Clinical modules
EDC	Included	Included	Included
CTMS	Included	Included	Included
eTMF	Included	Included	Included
Protocol Builder and SAP Builder	Included	Included	Included
eConsent and ePROEarly access	Not included	Included	Included
Cross-study dashboards	Not included	Included	Included
Scale
Active studies	1	Up to 3	Custom
Sites	Up to 20	Expanded	Custom
Study configuration support	Standard	Dedicated	Dedicated
Compliance foundation
Append-only audit trail	Included	Included	Included
Part 11-ready electronic signatures	Included	Included	Included
Validation documentation	Standard	Standard	Custom services

Value

The commercial case

One platform instead of four vendors

A single study on separate EDC, CTMS, eTMF and statistical tooling routinely carries four contracts, four validation efforts and manual reconciliation between them. Single Study is $33,000 per year for one active study, with everything on one record set.

No reconciliation between EDC, CTMS and eTMF
Protocol, SAP and monitoring plan drafted in the same system that runs the study
Reproducible analysis foundation instead of ad-hoc statistical exports
Per-study pricing, so cost tracks your portfolio

Questions

ClinicalOS pricing FAQ

ClinicalOS is early access — what does that mean commercially?: Early access means we onboard a limited number of sponsors with direct configuration support and an agreed scope, rather than self-service checkout. Pricing is as published; the engagement starts with a demo and a scoping call.
What is an active study?: A study that is open for data entry or monitoring. Closed-out studies remain fully readable and exportable at no additional subscription cost.
Can we cancel?: Subscriptions run for the committed term. Annual plans do not auto-escalate mid-term, and you can choose not to renew with 30 days' notice before the renewal date. Month-to-month plans, where offered, can be cancelled at the end of any billing month.
How much does annual billing save?: Annual commitment is the recommended option and is priced roughly 15-20% below the equivalent month-to-month rate. The exact saving for each plan is shown on its card when you switch the billing toggle.
Is onboarding included?: Standard onboarding — tenant setup, configuration walkthrough, administrator training and the standard validation documentation — is included on self-service tiers. Assisted implementation, data migration and executed validation are optional paid services, quoted before you buy. Enterprise implementation is scoped in your agreement.
Are there mandatory implementation fees?: No. Nothing is invoiced that is not on your order form. If your deployment needs assisted implementation or executed IQ/OQ, we quote it up front as an optional service rather than adding it later.
How are users counted?: Pricing is based on edit and power users — people who create, review, approve or sign records. Read-only, training-only and basic users are generous by design, because a quality or regulatory system only works when everyone can see it.
Is AI included?: AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Do we pay for updates?: No. Product updates, new capability within your tier and regulatory content updates are part of the subscription. Version history and validation impact notes are published with each release.
What support is included?: All plans include email support from people who have worked in regulated environments. Professional and above include prioritised response targets; Enterprise agreements can define named contacts and response commitments.
What does Enterprise add?: Multi-site and unlimited scale, SAML/OIDC and SCIM-ready provisioning, dedicated validation support, custom retention and data residency, API and integration work, and priority onboarding. Enterprise is always a quoted annual agreement.
Can we upgrade later?: Yes. Applications share one tenant and one identity, so moving up a tier or activating another Qevatrix application makes your existing records available immediately — there is no migration and no re-keying. Upgrades are pro-rated.
Can we get our data out?: Always. Records, revisions, signature manifests and the audit trail export to open formats (CSV and PDF packages), and Enterprise agreements can add scheduled or API-based extraction.

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