Start with the contract

Your clinical trial agreement and budget decide what you can invoice, how often, and where to send it. Some sponsors pay visit fees automatically from data entered in their system, while many other items need an invoice from the site. Check which is which for every study.

What sites commonly invoice for

Every contract is different, but look for these items:

  • Start-up fees: regulatory work, training and study setup
  • Per-visit payments: procedures and staff time for each completed visit
  • Screen failures: work on subjects who didn't qualify, which may be capped
  • Unscheduled visits: extra visits and repeat procedures the protocol allows
  • Pass-through costs: items such as IRB fees, shipping and subject stipends
  • Administrative fees: monitoring visits, audits, amendments and re-consent
  • Close-out and archiving: closing the study and storing records

Also check for overhead, which may be built into rates or added on top, and holdbacks, where part of each payment waits until the study closes.

A simple monthly routine

  • List every visit and billable event completed since the last invoice
  • Match each one to its rate in the contract budget
  • Confirm the documentation is complete before billing it
  • Check that nothing was already invoiced or paid automatically
  • Send the invoice with the protocol number, site number and subject numbers only
  • Track what's outstanding and follow up on anything overdue

Avoid billing twice

If a sponsor pays for a procedure, it generally shouldn't also be billed to the patient or their insurance. A coverage analysis helps your practice decide which items go where. Your billing team and compliance advisor should review this for each study.

Make invoices come from the record

Rebuilding an invoice from spreadsheets is where items get lost. PAS OneCore generates invoices from performed visits and your rates, then cross-checks them against study records.

This guide is general information, not legal, billing or financial advice. Follow your contract, and get professional advice on your own situation.