With this Article we are going to share our experience around negotiating any invoiceable costs in the study budgets for clinical sites. We will focus on procedural costs and site specific fees and mention our most common challenges, providing examples from day to day interactions.

The Invoiceable items are hardly avoidable when negotiating clinical trial site budgets. The range of invoiceables is quite extensive but can be divided into two main groups.

1. Items that are not applicable for every patient (aka Procedural costs): this can cover traditionally ‘expensive’ procedures such as radiological tests and procedures (CT, MRI, PET, etc.), pregnancy and other gender/age-specific tests. These are usually excluded from the per-visit fees and are listed separately in the budget.

The payment of such procedures is generally made after the procedure is performed during the next payment round (subject to verification procedures, of course).

2. One-time or regular budget items that are applicable on the site level (aka Administrative fees or Site costs): this includes Start-up, Close-out, Record retention (archiving) fees, as well as maintenance, audit, monitoring costs.

This group of fees can be very wide at site level and requires special attention of the negotiator. It shall be thoroughly assessed if a fee requested by the Site can be accepted as such.

For instance, monitoring fee can be highly discouraged by some Sponsors meaning that Site’s participation in monitoring activities is actually what is already covered in per-visit fees. Audit/inspection fees are usually accepted with a note ’not-for-cause’, meaning that the Sponsor can accept the fee, but only if such audit/inspection is not a result of site’s omissions or misconduct.

Another point of special attention concerns timeline for payment of an administrative fee. As a real-life example, the Site asks to pay Start-up fee before the clinical trial agreement is fully executed. Can we meet this site’s request? The answer can be either Yes or No. Let’s puzzle this out: first, the negotiator shall investigate the Sponsor’s position of the before-the-contract-is-signed payment. In parallel, the negotiator shall assess if such payment is possible on the local level.

Specifically, payment-before-the-contract can be possible in countries that utilize invoice-only model of payment, i.e., when invoice is sufficient, if it is accepted by the payer. But, say, in some Eastern European countries invoice cannot be issued not being attached to a contract – in such a case payment of start-up fee before the contract formally exists (even it is approved by the Sponsor) can cause a lot of headache for the Sponsor as such payment can be deemed illegal and influencing the party’s will to enter into the contract with all the reputation and legal consequences for both Site and Sponsor.

Thus, it is the role of the negotiator to balance between Site’s and Sponsor’s interests considering the local regulatory environment – at each stage of site budget and contract negotiation.

Here is where our team steps in and shares with the Sponsor the Site’s regular process, or how flexible they can be from experience.

In terms of what the Sponsor can accommodate, the site will also receive support from CTA Focus, detailing the parameters in which the clinical study is set-up.