Built for clinical research sites

Accelerated Study Startup for site teams.

Upload your protocol once and get a draft QCT checklist, a Medicare Coverage Analysis with cited evidence, CPT codes with billing modifiers, and a sponsor-budget comparison — all reviewed and signed off in one workspace.

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  • Available now: QCT checklist, Medicare Coverage Analysis with evidence, CPT codes & modifiers, budget comparison, sign-off & audit trail
  • Coming next: first-draft budget generation

Built for clinical research operations teams at

  • Academic medical centers
  • Hospitals & health systems
  • Cancer centers
  • Clinical trial offices
  • Research administration teams
  • Pre-award & finance teams
  • Site startup teams
  • Coverage analysis teams
The problem

Turn startup documents into structured site workflows

Clinical trial startup at sites depends on a tangle of protocols, sponsor emails, shared drives, internal spreadsheets, coverage analysis queues, budget workbooks, and manual handoffs between teams.

We help site teams convert incoming study documents into structured review workflows — QCT checklist, Medicare Coverage Analysis, and CPT recommendations today, with first-draft budgeting next.

Protocol PDFs
Sponsor emails
Shared drives
Internal spreadsheets
Coverage analysis queues
Budget workbooks
Manual handoffs
Sponsor packets
Available now

QCT, coverage analysis, and CPT — live today

Upload study documents and generate a draft QCT review, Medicare Coverage Analysis grounded in your organization’s policies and selected guideline sources, ranked CPT recommendations with billing modifiers, and a sponsor-budget comparison — designed as a first pass before final site sign-off.

It helps your team answer questions like:

  • Does the trial evaluate an item or service in a Medicare benefit category?
  • Which procedures are routine care vs research-driven — and does that follow our billing policies?
  • What CPT codes and billing modifiers fit each schedule-of-activities line item?
  • Does the sponsor budget match what the protocol actually requires?
  • Which items require human review, and where is the supporting evidence?
  • Who reviewed, changed, and signed off on this assessment?
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Capabilities

What you can do today

One platform for site startup — QCT review, Medicare Coverage Analysis, CPT recommendations with modifiers, budget comparison, and sign-off are live, with first-draft budgeting next.

Available now

Qualifying Clinical Trial checklist

Automatically review study documents against QCT criteria and generate a draft site-facing review.

  • Reduce manual protocol review time
  • Standardize QCT determinations
  • Identify missing or ambiguous information
  • Create an auditable first-pass checklist
  • Flag uncertain items for human review
Available now

Medicare Coverage Analysis

Use protocol documents and schedules of activities to support first-pass MCA preparation — grounded in Medicare guidelines and your own billing policies.

  • Extract study arms, visits, and procedures
  • Distinguish routine-care vs research-driven items with cited evidence
  • Apply organization billing policies and admin-selected guideline sources
  • Flag procedures requiring review
Available now

CPT codes & billing modifiers

Suggest ranked CPT codes and clinical-trial billing modifiers for extracted schedule-of-activities line items so coverage and billing teams start from validated AMA descriptors.

  • Rank candidate codes per procedure
  • Suggest Q0/Q1 and other billing modifiers per designation
  • Ground suggestions in AMA CPT descriptors
  • Keep analysts in control of final code selection
Available now

Budget comparison & sign-off

Upload the sponsor budget workbook, compare it against the protocol’s schedule of activities and consent form, then sign off electronically.

  • Flag items in the budget but not the protocol, and vice versa
  • Check congruency across ICF, SOA, and budget
  • Electronically sign and lock finalized assessments
  • Track every change in a per-trial audit trail
Coming next

First-draft budget

Generate a first-pass budget draft from study documents, schedule of activities, and site-specific assumptions — so finance starts from a draft, not a blank sheet.

  • Map procedures to internal price assumptions
  • Identify pass-through costs
  • Flag missing sponsor budget information
  • Produce a draft workbook for finance handoff
Why sites need this

Site startup is high-stakes — but still too manual.

Before a study can activate, site teams need to answer operational and reimbursement questions quickly. Today, much of that work happens across email, spreadsheets, and disconnected systems.

  • Is this a qualifying clinical trial?
  • What documents are missing?
  • Who needs to review the protocol next?
  • What needs coverage analysis?
  • What should be billed to Medicare, the sponsor, or another payer?
  • What does finance need to start the budget?
  • Which internal team owns the next step?
Site benefits

What this changes for your team

Reduce manual protocol review

Start with a draft QCT checklist instead of manually searching through protocol documents.

Standardize determinations

Use a consistent review structure across studies, analysts, and departments.

Improve handoffs

Pass structured QCT, coverage, and CPT outputs to the right internal teams earlier in startup.

Find missing information faster

Flag ambiguous or incomplete sections before they delay MCA or budget review.

Build toward full startup automation

Use QCT, coverage analysis, and CPT recommendations today, then expand into first-draft budget support as that workflow matures.

Site workflow

From protocol intake to a signed-off assessment

A repeatable five-step path from incoming sponsor documents to a reviewed, signed, and auditable coverage assessment.

  1. Available now

    Upload study documents

    Upload the protocol, schedule of activities, consent form, and sponsor budget. Study metadata like NCT number and PI is extracted automatically.

  2. Available now

    Review the QCT checklist

    Get a draft Qualifying Clinical Trial checklist — including your institution’s own questions — with evidence citations for every answer.

  3. Available now

    Run coverage analysis

    Procedures are extracted from the schedule of activities and assessed against Medicare guidelines and your organization’s billing policies, with cited evidence.

  4. Available now

    Confirm CPT codes & modifiers

    Ranked CPT suggestions per procedure, grounded in AMA descriptors, with clinical-trial billing modifiers like Q0/Q1 pre-suggested.

  5. Available now

    Sign off & export

    Compare against the sponsor budget, resolve discrepancies, then electronically sign to lock the assessment — every step lands in the audit trail.

Who uses it at the site

Built for every team in site startup

One workspace, multiple roles. Each team gets the tools and visibility they need without losing the shared context.

Clinical Trial Office leadership

Get visibility into study startup queues, delays, and team workload across sites and studies.

Coverage analysis teams

Start QCT, coverage analysis, and CPT review from structured draft outputs instead of raw protocol documents.

Pre-award & finance teams

Receive cleaner study inputs for budget development, sponsor negotiation, and finance handoff.

Regulatory & startup coordinators

Track document status, missing information, and next-step ownership across the startup lifecycle.

Research administrators

Standardize study intake and reduce repeated sponsor follow-up across research teams.

Security

Designed for clinical research environments

Permissions, audit history, and storage controls built for the way site research operations and IT teams actually work.

Role-based access

Granular access by organization, role, and study so each team only sees what is relevant to them.

Secure document storage

Encrypted at rest and in transit, with document-level access controls and retention policies.

Audit-friendly history

Every workflow change is traceable with user, timestamp, and action for site QA and review.

Organization-level permissions

Cleanly separate departments, programs, and external collaborators inside one workspace.

Configurable user roles

Tailor reviewer, approver, finance, and coordinator permissions to match your site governance.

Enterprise security support

Single sign-on, domain restrictions, and session policies designed for clinical research environments.

FAQ

Common questions

Is the full startup platform available today?
QCT checklist automation, Medicare Coverage Analysis, and CPT code recommendations are available today. First-draft budget generation is coming next.
Does this replace coverage analysts?
No. It is designed to support human review by preparing structured drafts, evidence summaries, CPT suggestions, and missing-information flags so analysts spend less time on first-pass extraction and organization.
Can we use only the QCT tool?
Yes. Sites can run QCT checklist automation on its own, or use coverage analysis and CPT recommendations together as needed.
Is the QCT or coverage output final?
No. These workflows produce draft reviews intended for site confirmation. Reviewers confirm, edit, or complete any ambiguous answers and code selections before finalization.
Who at the site would use this?
Clinical trial office leadership, coverage analysis teams, pre-award and finance teams, regulatory and startup coordinators, and research administrators — anyone touching study startup documents.
Can this work with our existing process?
Yes. The workflows are designed to fit into existing site startup and coverage analysis processes rather than replace them. You can begin with intake, QCT, and coverage review, then layer in first-draft budgeting as it matures.

Start with QCT, coverage, and CPT.
Build toward faster site startup.

Use QCT checklist automation, Medicare Coverage Analysis, and CPT recommendations today — then expand into first-draft budget support as your site workflow matures.

Open the app

Available now: QCT · Coverage analysis · CPT · Coming next: first-draft budget