I just got back from a conference where I spent three days asking one simple question over and over again to hundreds of PI's, Trial Managers, and Study Coordinators: "Do you include line items for study inventory & supply management in your Sponsor budgets?"
9 times out of 10 the answer was, "No - but I'd love to learn how!"
You're Leaving Money on the Table
Clinical trial budgeting is a complex process, which makes it easy to leave money on the table. As I learned at the conference, trial inventory & supply management is one common area that study sites consistently miss in their budgeting process.
Your site runs on an extremely tight budget with limited wiggle room while your studies require lots of study drugs, lab kits, devices, equipment, shippers, and bulk supplies. When you don't account for the time and cost burden of ordering, receiving, storing, managing, using, and returning study inventory you're unknowingly stretching your budget to the breaking point.
Don't you wish Sponsors could see and understand your site's true cost when it comes to clinical inventory & supply management? It's clear that there's a disconnect.
Case in point: They'll send (or even worse auto ship) a batch of lab kits or other study supplies to your site that in no way correlates to your current patient load or projected enrollment.
They mean well. They just don't have visibility into what's happening at your site right now so they don't know how much you need. Sponsors just want to ensure that you have enough study inventory & supplies on hand to serve your patients.
But you're left holding the bag, and all the lab kit boxes, and the shippers, and equipment, etc. All of it cluttering and taking up your valuable space, interfering with patient care.
There must be a better way, right?
Bridging the Gap
The solution is actually quite simple, but it relies on you. Your site can fix this problem by detailing your study inventory & supply management costs in the trial budget. This is the quickest, most direct way to educate Sponsors about the things that your site must do to manage all the stuff that it takes to pull off a clinical trial.
I know it’s a headache to dig through your records, estimating how much time and money your team will spend on study inventory & supply management. But here's the good news: You will finally get paid for the work and resources you’ve been absorbing in overhead for years. Suddenly your budget will feel a little more flexible, you'll have a little bit more cash on hand to cover your expenses, and your margins will start to head in the right direction.
Now let's talk about how to pull this off.
Turn Sponsor Pushback into a Budget Conversation
Budgeting is more of a conversation than a hard line in the sand. The truth is, you probably will get some pushback from Sponsors who consider study inventory & supply management nothing more than a cost of doing business for clinical research sites.
The best way to explain what it really takes to conduct a Sponsor's study is to put a dollar sign on clinical supply management. And while you're at it, share this information with your peers to help them recover their costs and educate their Sponsors.
So what line items should you include in your budgets?
Here’s a start…
- Time & cost to manage all drug and material supplies, unless they are standard of care.
- Storage space by the square foot or shelving unit.
- You have archival storage fees, right?
- Now just include onsite material storage fees too.
- The time cost of breaking down lab kits for disposal or return shipping.
- The time cost to determine & report your study inventory & supply levels at study closeout.
- The time cost of ordering, receiving, and using study inventory & supplies.
- The time cost of managing study equipment.
This is just a partial list to jog your thinking. I'd love to hear what your clinical research site is doing to recover your study inventory and supply related costs!
Written by Rust Felix
Rust Felix is the Co-founder and CEO of Slope. He's passionate about helping Sites & Sponsors improve recruitment & retention through better inventory management.