Negotiating a clinical site budget is daunting. All those costs and line items can make you cross-eyed!
However, there’s an approach which is both simple but still hews to your bottom line. And it works whether you’re doing the negotiation (as a sponsor employee) or through your CRO.
First, decide on a maximum overage for the Total Per Patient Cost (PPC). If a site returns a PPC that falls within this cap, automatically approve it.
- Format your cap in whatever way, e.g. 10% over budget or $10K over budget.
- You can create a separate cap for each country/region or even site type (large institution vs community clinic). After all, standard costs differ across these categories.
- Ensure this cap is discussed with and approved by the right stakeholders – depending on the Sponsor, this could be the Clinical Program Manager, Director of Clinical Operations, or someone in Finance.
Next, define (and document!) an escalation path to avoid deadlocks.
- For example: Approve budget if PPC is under cap; if not, push back via email a max of 2x. If still no consensus, escalate to phone call w/ALL key stakeholders. Decide on line item costs and verbally approve budget during call.
- If using a CRO, communicate the cap and path to them! They shouldn’t escalate a budget to you unless the PPC surpasses the cap.
If the site’s PPC surpasses the cap, there are usually a few items driving the overage.
- Suggest new rates for these items to bring the PPC within the cap. Your rationale should state that these costs deviate greatly from those in the study budget template.
The site’s PPC may also surpass the cap due to inclusion of new line items.
- For example: “EDC Entry Resource”.
- Again, suggest the removal of these items or lower rates. This time, ask the site to explain why these items were added.
If you’re still unable to negotiate the PPC to fall within the cap, you may just be dealing with an expensive site.
- However, before approving their budget, compare it against another budget for the same institution. Ideally, this would be for a similar study.
- If you have another budget for the same institution for a dissimilar study, at least confirm that the most expensive line items are comparable. If you work at a small start-up and don’t have other studies, ask your industry colleagues! They may know offhand whether an institution is expensive or not.
At the end of the day, comparing each line item cost in the site budget against the study budget template is tedious and inefficient. Instead, maintain the Big Picture. Start with the PPC, assess key drivers and comparables, and negotiate quickly from there.
