StudyOS pricing — clinical study operations

Run your clinical study with a smaller team.

StudyOS is priced per active study, not per person. Every plan includes unlimited users, a free Investigation Site Portal for your sites, the append-only audit trail, Part 11-ready electronic signatures and AI that keeps the study moving between visits.

Plans

Priced per active study

Annual billing runs about 15-20% below month-to-month. Completed studies move to archive access rather than staying at the active-study rate.

StudyOS Launch

Pilot, feasibility and small investigator-led studies, small registries, PMCF studies and early-stage device companies

$833/month

billed annually, per active study · $9,995 per year

1 active study · up to 3 investigation sites · up to 150 subjects

Unlimited sponsor, investigator, coordinator, CRA and site users. AI included — no separate AI subscription.

  • AI Study Assistant
  • Study timeline and milestone management
  • Site onboarding
  • Study document tracking
  • Audit trails
  • Basic automated reminders
  • Investigation Site Portal
  • Basic query and issue management
  • Basic AI study summaries
  • Personnel and coordinator handoff continuity
  • Optional ClinicalOS integration
  • Optional EvidenceOS integration
Most popular

StudyOS Professional

Multi-site medical-device studies, post-market studies, prospective and retrospective programmes, and FDA evidence-generation work

$2,083/month

billed annually, per active study · $24,995 per year

1 active study · up to 20 investigation sites · up to 1,000 subjects

Unlimited sponsor, investigator, coordinator, CRA and site users. AI included throughout, fair use.

  • Everything in Launch, plus:
  • Advanced study timeline and milestone management
  • Site onboarding workflows
  • Study document management
  • Comprehensive audit trails
  • Advanced automated reminders
  • Automated missing-data follow-up
  • Automated missing CT, imaging and document follow-up
  • Query and issue management with monitoring workflows
  • AI-generated study summaries
  • AI site-performance monitoring
  • Standard integrations and API access
  • Dedicated customer success support
  • ClinicalOS and EvidenceOS integration

StudyOS Advanced

Large multi-site studies, complex or higher-risk clinical programmes and sponsors managing larger subject populations

$2,916/month

billed annually, per active study · $34,995 per year

1 active study · up to 50 investigation sites · up to 5,000 subjects

Unlimited users of every role. Advanced AI study operations included.

  • Everything in Professional, plus:
  • Advanced AI study operations
  • Advanced automated site follow-up
  • Risk-based monitoring
  • Advanced monitoring workflows
  • Custom study workflows
  • Advanced API and integration capability
  • Single Sign-On
  • Advanced role management
  • Advanced dashboards and custom alerts
  • Custom sponsor workflows
  • Enhanced administrative controls
  • Priority customer support

StudyOS Enterprise

CROs, large sponsors, multi-study organisations and manufacturers with ongoing clinical programmes

Custom pricing

annual agreement

Multiple active studies · portfolio-level scale · unlimited users

Multi-study AI intelligence with custom controls. Starting at approximately $69,000 per year.

  • Multiple active studies
  • Portfolio-level dashboards and cross-study analytics
  • Enterprise user management and advanced permissions
  • SSO and API integrations
  • Custom workflows and enterprise security controls
  • Dedicated onboarding, customer success manager and custom training
  • Multi-study AI intelligence
  • ClinicalOS and EvidenceOS integration
  • Investigation Site Portal
  • Priority support and custom service-level options
Contact Qevatrix

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

Completed Study Archive

When a study closes, it moves to secure read-only access — the full record set, audit trail and documents remain available for inspection and evidence work at a significantly reduced rate rather than the active-study price. Archive access is included for the remainder of the paid term and renews at the archive rate.

Help me choose

Find the right StudyOS plan

Answer a few questions about your study and we will point you at the plan that fits.

Study type

Compare

What each plan includes

Study management, AI automation, clinical operations, compliance and ecosystem integration across the four StudyOS plans.

StudyOS plan feature comparison
CapabilityStudyOS LaunchStudyOS ProfessionalStudyOS AdvancedStudyOS Enterprise
Study management
Active studies111Multiple
Investigation sitesUp to 3Up to 20Up to 50Custom
SubjectsUp to 150Up to 1,000Up to 5,000Custom
Unlimited sponsor, site and CRA usersIncludedIncludedIncludedIncluded
Study timelines and milestonesIncludedAdvancedAdvancedAdvanced
Site onboardingIncludedWorkflowsWorkflowsWorkflows
AI automation
AI Study AssistantIncludedIncludedIncludedIncluded
AI study summariesBasicIncludedIncludedMulti-study
Automated remindersBasicAdvancedAdvancedAdvanced
Missing-data detectionNot includedIncludedIncludedIncluded
Automated site follow-upNot includedIncludedAdvancedAdvanced
Missing CT detectionNot includedIncludedIncludedIncluded
Missing imaging detectionNot includedIncludedIncludedIncluded
Missing-document follow-upNot includedIncludedIncludedIncluded
AI site-performance monitoringNot includedIncludedIncludedIncluded
Risk-based monitoringNot includedNot includedIncludedIncluded
Clinical operations
Investigation Site PortalIncludedIncludedIncludedIncluded
Query managementBasicIncludedIncludedIncluded
Monitoring workflowsNot includedIncludedAdvancedAdvanced
Personnel handoff continuityIncludedIncludedIncludedIncluded
Site task trackingIncludedIncludedIncludedIncluded
Escalation workflowsNot includedIncludedCustomCustom
Compliance and administration
Audit trailIncludedIncludedIncludedIncluded
Roles and permissionsIncludedIncludedAdvancedEnterprise
Single Sign-OnNot includedNot includedIncludedIncluded
API accessNot includedStandardAdvancedEnterprise
Custom integrationsNot includedNot includedIncludedIncluded
Custom workflowsNot includedNot includedIncludedIncluded
Qevatrix ecosystem
ClinicalOS integrationOptionalIncludedIncludedIncluded
EvidenceOS integrationOptionalIncludedIncludedIncluded
Investigation Site PortalIncludedIncludedIncludedIncluded
Cross-platform workflowIncludedIncludedIncludedIncluded
Portfolio dashboards and cross-study analyticsNot includedNot includedNot includedIncluded

Professional services

Get the study configured properly, once

Most delay in a clinical study comes from setup. AI Study Launch turns your protocol into a running study in StudyOS.

AI Study Launch fee waived with an annual StudyOS Professional or Advanced subscription

Qevatrix AI Study Launch

$4,995one-time

A guided configuration engagement that turns your protocol into a running study in StudyOS, with the AI, follow-up and monitoring behaviour set up around how your study actually operates.

Talk to us first
  • Protocol review
  • Study configuration
  • Study milestones
  • Study timelines
  • Site setup
  • Investigator workflows
  • Visit schedules
  • Required documents
  • Follow-up requirements
  • Monitoring workflows
  • Alerts
  • Study tasks
  • Role permissions
  • Dashboards
  • Study-specific AI instructions
  • Investigation Site Portal configuration
  • ClinicalOS integration
  • EvidenceOS integration
  • Automated communication setup

Return on investment

Where the administrative burden goes

StudyOS is designed to reduce the coordination work that consumes clinical teams between visits.

Traditional study operations

Clinical personnel spend significant time:

  • Checking spreadsheets
  • Sending reminders
  • Following up with sites
  • Searching for missing information
  • Preparing status reports
  • Manually monitoring deadlines

StudyOS

AI continuously helps:

  • Detect outstanding items
  • Prioritise tasks
  • Contact the appropriate site personnel
  • Escalate overdue items
  • Summarise study status
  • Identify high-risk sites
  • Maintain study continuity
  • Keep authorised replacement personnel informed

Estimate my potential study savings

An indicative model, not a quote. It values administrative time released, using the assumptions published on our ROI evidence page.

$
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months

The link reopens this page with the same inputs. The PDF is an estimate summary that repeats every assumption above.

Replace manual study administration with intelligent clinical operations

Most clinical study cost is people time spent chasing sites, checking spreadsheets and assembling status reports. StudyOS is designed to reduce that administrative workload so a smaller clinical team can run the same study, and so outstanding items surface before they become delays.

  • Repeated follow-up emails, site status calls and spreadsheet tracking
  • Missing-data, CT, imaging and document chasing
  • Study milestone monitoring and query tracking
  • Manual status reporting and executive study summaries
  • Coordinator turnover disruption and site-performance tracking

Enterprise

Portfolio and multi-study programmes

Enterprise agreements are scoped on active studies, sites, subjects, complexity and integrations. Use the estimator for an indicative range before you talk to us.

months
Study complexity

The link reopens this page with the same inputs. The PDF summary is labelled as an indicative estimate, not a quote.

Qevatrix ecosystem

From study planning to regulatory-ready evidence

StudyOS works on its own, and becomes considerably more powerful connected to ClinicalOS and EvidenceOS.

  1. StudyOS logo

    StudyOS

    Study design, study operations, sites, investigators, tasks, monitoring and follow-up.

  2. ClinicalOS logo

    ClinicalOS

    Clinical data capture, patient-level data management, outcomes, imaging and study datasets.

  3. EvidenceOS logo

    EvidenceOS

    Evidence synthesis, analysis, literature integration, clinical evidence generation and reports.

  4. Investigation Site Portal logo

    Investigation Site Portal

    Investigator and coordinator interaction, document submission, site tasks and missing-data responses.

Regulatory-ready clinical evidence

StudyOS can be purchased on its own. Connected to ClinicalOS and EvidenceOS it runs on one tenant, one identity and one audit trail, so study operations, clinical data and evidence generation stop being three disconnected workflows.

Qevatrix Clinical Intelligence Suite

From study planning to regulatory-ready evidence in one connected AI platform.

  • StudyOS — clinical study operations, monitoring and AI follow-up
  • ClinicalOS — clinical data capture, EDC, CTMS and eTMF
  • EvidenceOS — registries, evidence synthesis and reporting
  • Investigation Site Portal — free for participating sites

Approximately 15-20% below the combined price of each platform purchased separately

Suite pricing is confirmed on your configuration — the number of active studies, registries and connected sites determines the combined agreement.

Build My Clinical Intelligence Suite

Questions

StudyOS pricing FAQ

What counts as an active study?
An active study is one currently being configured, enrolled, monitored, followed or actively managed through StudyOS. Studies that have completed can move to Completed Study Archive — secure read-only access at a significantly reduced rate — so you never pay the full active-study price indefinitely.
Do you charge per user?
No. Every plan includes unlimited sponsor, investigator, coordinator, CRA, consultant, regulatory, quality, imaging-review and data-review users. Clinical studies see personnel turnover, and replacing a coordinator should never require buying another licence.
Do we buy AI credits?
No. AI is included throughout StudyOS with reasonable internal fair-use limits. There is no separate AI subscription and no customer-facing credit counter.
What is AI Study Launch?
A $4,995 one-time configuration service covering protocol review, study configuration, milestones and timelines, site setup, investigator workflows, visit schedules, required documents, follow-up requirements, monitoring workflows, alerts, tasks, permissions, dashboards, study-specific AI instructions, Site Portal configuration and ClinicalOS/EvidenceOS integration. The fee is waived with an annual Professional or Advanced subscription.
Is StudyOS a compliance guarantee?
No. StudyOS is designed to support GCP-aligned clinical workflows, controlled study processes, traceability and auditability. It helps you identify outstanding tasks and missing information and reduces manual administrative workload — it does not approve records or replace qualified human review.
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.