Built for clinical research sites

Accelerated Study Startup for site teams.

Streamline protocol intake, QCT review, MCA preparation, and budget handoff in one site-focused workflow.

Try QCT review
  • Available now: Qualifying Clinical Trial checklist automation
  • In development: document routing, Medicare Coverage Analysis, first-draft budget

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 — starting with the Qualifying Clinical Trial checklist and expanding into document routing, MCA preparation, and first-draft budgeting.

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

QCT checklist automation — live today

Our first available workflow focuses on the Qualifying Clinical Trial checklist. Upload study documents and generate a draft QCT review designed to be used as a first-pass before final site determination.

It helps your team answer questions like:

  • Does the trial evaluate an item or service in a Medicare benefit category?
  • Does the trial have therapeutic intent?
  • Does it enroll diagnosed beneficiaries?
  • Does the study appear to meet qualifying criteria?
  • Which items require human review?
  • Where does the supporting evidence appear in the protocol?
Open the app
Product pipeline

What we are building

One platform that grows with your site startup workflow — starting with QCT automation today, and expanding into routing, MCA, and budget drafting 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
  • Route uncertain items for human review
In development

Document routing

Classify incoming study documents and route them to the correct internal team — protocol to coverage analysis, budget template to finance, consent to regulatory.

  • Reduce manual triage at intake
  • Flag missing documents for follow-up
  • Organize sponsor packets into a structured intake record
  • Prevent documents from sitting in the wrong inbox
In development

Medicare Coverage Analysis support

Use protocol documents, schedules of activities, and QCT outputs to support first-pass MCA preparation — without replacing the analyst.

  • Extract study arms, visits, and procedures
  • Distinguish routine-care vs research-driven items
  • Flag procedures requiring review
  • Prepare structured MCA draft inputs
Planned

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

Route documents and tasks 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

Begin with QCT today, then expand into MCA, document routing, and budget support as workflows mature.

Site workflow

From protocol intake to activation support

A repeatable five-step path from incoming sponsor documents to a tracked, ready-to-activate study.

  1. Receive study documents

    Upload protocol packets, schedules of activities, sponsor budget templates, consent forms, and related startup materials.

  2. Available now

    Run QCT review

    Generate a draft Qualifying Clinical Trial checklist using the available QCT workflow.

  3. Route follow-up tasks

    Assign ambiguous or incomplete items to the appropriate site team for review.

  4. Prepare for MCA & budget review

    As workflows become available, use structured outputs to support MCA preparation and first-draft budgeting.

  5. Track startup status

    See which studies are waiting on QCT, MCA, budget review, sponsor clarification, or internal approval.

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 and MCA 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?
No. The available product today is the QCT checklist workflow. Document routing, MCA support, and first-draft budget generation are in development and rolling out next.
Does this replace coverage analysts?
No. It is designed to support human review by preparing structured drafts, evidence summaries, 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 start with QCT checklist automation today and expand into document routing, MCA support, and budget drafting as those workflows become available.
Is the QCT output final?
No. The QCT workflow produces a draft review intended for site confirmation. Reviewers confirm, edit, or complete any ambiguous answers 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 initial workflow is designed to fit into existing site startup and coverage analysis processes rather than replace them. You can begin with intake and QCT review, then layer in additional workflows as they mature.

Start with QCT automation.
Build toward faster site startup.

Use the available QCT checklist workflow today, then expand into document routing, MCA preparation, and first-draft budget support as your site workflow matures.

Try the QCT app

Available now: QCT checklist · In development: document routing, MCA, budget