DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Why Your Clinical Trial Contract Is Leaving Cash on the Table
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
How do I make sure that the sponsor contract actually covers my site's costs? So sponsors often propose budgets that don't actually reflect real site costs. You need a contract that itemizes everything. I'm talking about screen fails, pharmacy prep, regulatory time, storage, and coordinator overtime. If these aren't listed, you eat the cost. I recommend building a detailed budget grid. You want to tie to specific CPT codes and task-based line items. You want to push for per patient per activity language, not big lump sums. Now that's not always possible, but that's the goal. Overhead is problematic nowadays, let's be honest. We know this under the Trump administration. But if you can, add overhead. It can be anywhere up to 30% sometimes. And in large academic institutions, it's even more. Ensure that the contract lets you bill for out-of-scope tasks, things like unexpected serious adverse events and follow-up associated with that. Key area of consideration. What happens when the contract ends? What services are paid for in that scenario when you're 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, you don't get paid. Negotiating this upfront prevents disputes later and keeps your site financially healthy. Call, click, or email.
