StudyOS

Available now

Run your clinical study with a smaller team.

AI-powered clinical study management built for medical-device teams. StudyOS runs study timelines, sites, investigators, tasks, monitoring and follow-up, and uses AI to detect outstanding items, chase missing CTs, images, documents and data, and keep the study moving when personnel change. Sponsor isolation and portfolio visibility scale it from one study to a CRO-sized programme.

Built for: Medical-device sponsors, clinical affairs teams, CROs and investigation sites

About this app

Give sponsors and CROs oversight of study execution across sites and portfolios without touching identifiable patient data.

StudyOS is the operating platform for contract research organizations and sponsor oversight teams: it tracks study and site progress, data completeness and coordinator activity across the investigations running in ClinicalOS.

What you can do

Review site data oversight across the studies in the organisation
Monitor data completeness and follow-up status by site
Coordinate sponsor and CRO review of study execution

Problems it solves

Sponsors with no real-time visibility of site data capture
Multi-sponsor CRO portfolios tracked in separate trackers per study
Oversight processes that require sharing identifiable patient records

Who it is for

Contract research organizations
Sponsor clinical oversight and monitoring teams
Study and project managers
Clinical quality reviewers

Works with

StudyOS manages study execution, ClinicalOS supports clinical operations at the sites, and EvidenceOS consolidates the resulting evidence — the same investigation seen at three levels, without duplicating data entry.

Hard sponsor isolation with cross-sponsor operational visibility for your team

Budgets, contracts, pass-throughs and site payments in the workflow

Resource and utilization planning tied to real study milestones

Capabilities

What StudyOS does

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

Multi-sponsor portfolio

Every sponsor's studies, documents and data are isolated from every other sponsor, while your operations team sees the whole book of work.

Budgets and contracts

Study budgets, change orders, pass-through costs, milestone-based invoicing and site payment schedules tracked against actual study progress.

Resourcing and utilization

Assign CRAs, coordinators, data managers and statisticians across studies with visibility into capacity, travel load and monitoring obligations.

Monitoring operations

Risk-based monitoring plans, visit scheduling, report workflows, follow-up letters and action closure across every sponsor engagement.

Sponsor reporting

Configurable sponsor-facing dashboards and status reports generated from live study data instead of hand-assembled spreadsheets.

Program governance

Program-level milestones, risks, issues and escalation paths spanning multiple studies under one clinical development plan.

Regulatory foundation

Standards it is built against

21 CFR Part 11
ISO 14155
Good Clinical Practice
Sponsor delegation and oversight documentation

Qevatrix Intelligence

Where AI helps — and where it stops

StudyOS drafts monitoring reports, status narratives and budget variance summaries. Sponsor-facing conclusions and contractual commitments stay with your people.

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

Modules

StudyOS module by module

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

AI Study Assistant

An AI assistant that knows your study — timelines, sites, outstanding items and next actions.

Study Timeline & Milestones

Milestones tied to real study progress, with slip projected before it happens.

Site Onboarding

From invitation to activated site with nothing lost in inboxes.

Study Document Tracking

Every essential document tracked, chased and audit-trailed.

Investigation Site Portal

A free, focused portal for your investigators and coordinators.

Queries, Issues & Monitoring

Query and issue management with monitoring workflows — risk-based on Advanced.

Oversight Dashboards & Sponsor Reporting

Sponsor dashboards and status reports generated from live study data.

Budgets, Contracts & Resourcing

Budgets, change orders, pass-throughs and site payments in the workflow.

Pricing

StudyOS plans

Run your clinical study with a smaller team. AI-powered clinical study management built for medical-device sponsors, CROs and investigation sites — priced per active study, never per user.

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

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.

Better together

StudyOS runs the study; ClinicalOS captures the data and EvidenceOS turns it into regulatory-ready evidence — one tenant, one identity, one audit trail.

Explore ClinicalOS

Prices in USD per active study, excluding applicable taxes. Annual prepayment is the recommended option and saves roughly 16-17% against month-to-month. Completed studies can move to a reduced-rate archive. Enterprise agreements are quoted on active studies, sites, subjects, integrations and services.

Compare

What is in each plan

StudyOS plan feature comparison
Capability	StudyOS Launch	StudyOS Professional	StudyOS Advanced	StudyOS Enterprise
Study management
Active studies	1	1	1	Multiple
Investigation sites	Up to 3	Up to 20	Up to 50	Custom
Subjects	Up to 150	Up to 1,000	Up to 5,000	Custom
Unlimited sponsor, site and CRA users	Included	Included	Included	Included
Study timelines and milestones	Included	Advanced	Advanced	Advanced
Site onboarding	Included	Workflows	Workflows	Workflows
AI automation
AI Study Assistant	Included	Included	Included	Included
AI study summaries	Basic	Included	Included	Multi-study
Automated reminders	Basic	Advanced	Advanced	Advanced
Missing-data detection	Not included	Included	Included	Included
Automated site follow-up	Not included	Included	Advanced	Advanced
Missing CT detection	Not included	Included	Included	Included
Missing imaging detection	Not included	Included	Included	Included
Missing-document follow-up	Not included	Included	Included	Included
AI site-performance monitoring	Not included	Included	Included	Included
Risk-based monitoring	Not included	Not included	Included	Included
Clinical operations
Investigation Site Portal	Included	Included	Included	Included
Query management	Basic	Included	Included	Included
Monitoring workflows	Not included	Included	Advanced	Advanced
Personnel handoff continuity	Included	Included	Included	Included
Site task tracking	Included	Included	Included	Included
Escalation workflows	Not included	Included	Custom	Custom
Compliance and administration
Audit trail	Included	Included	Included	Included
Roles and permissions	Included	Included	Advanced	Enterprise
Single Sign-On	Not included	Not included	Included	Included
API access	Not included	Standard	Advanced	Enterprise
Custom integrations	Not included	Not included	Included	Included
Custom workflows	Not included	Not included	Included	Included
Qevatrix ecosystem
ClinicalOS integration	Optional	Included	Included	Included
EvidenceOS integration	Optional	Included	Included	Included
Investigation Site Portal	Included	Included	Included	Included
Cross-platform workflow	Included	Included	Included	Included
Portfolio dashboards and cross-study analytics	Not included	Not included	Not included	Included

Value

The commercial case

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

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.

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