Clinical research sites lose money when sponsor contracts skip the real costs of running a study. In this episode, Darshan breaks down how to protect your site by building a detailed, task-based budget instead of accepting broad lump-sum payments. He explains why every activity needs to be itemized, from screen failures and pharmacy prep to coordinator overtime and regulatory time. You’ll hear practical tips on tying costs to CPT codes, adding overhead where possible, and making sure you can bill for out-of-scope work like unexpected SAEs and follow-up. He also highlights a commonly overlooked issue: what gets paid when the contract ends. Chart reviews, data queries, and PI closeout time all need clear language. If it’s not written down, it won’t get paid. This quick guide helps sites negotiate smarter and stay financially healthy. Call 302.252.6959 if you have questions, or email Darshan@Kulkarnilawfirm.com
www.kulkarnilawfirm.com
Episode Transcript
How do I make sure that the sponsor contract actually
(00:03):
covers my site's costs?
So sponsors often proposebudgets that don't actually
reflect real site costs.
You need a contract thatitemizes everything.
I'm talking about screen fails,pharmacy prep, regulatory time,
storage, and coordinatorovertime.
If these aren't listed, you eatthe cost.
(00:23):
I recommend building a detailedbudget grid.
You want to tie to specific CPTcodes and task-based line items.
You want to push for per patientper activity language, not big
lump sums.
Now that's not always possible,but that's the goal.
Overhead is problematicnowadays, let's be honest.
We know this under the Trumpadministration.
But if you can, add overhead.
(00:44):
It can be anywhere up to 30%sometimes.
And in large academicinstitutions, it's even more.
Ensure that the contract letsyou bill for out-of-scope tasks,
things like unexpected seriousadverse events and follow-up
associated with that.
Key area of consideration.
What happens when the contractends?
What services are paid for inthat scenario when you're
(01:04):
discussing PI time?
I'm talking about chart reviews,final visits, data queries, and
more.
The key is specificity.
If it's not written down, youdon't get paid.
Negotiating this upfrontprevents disputes later and
keeps your site financiallyhealthy.
Call, click, or email.
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