2-minute read | Part 1 of 2
Powerfully negotiate your site’s clinical trial budget with your sponsor/CRO by taking a three-prong approach:
- Evaluate protocols requirements
- Develop and calculate overhead
- Leverage your site’s strength and experience
Our recent webinar shared insights from resident BTC Network experts, Adam Schear, Senior Clinical Financial Analyst and Joey Nguyen, Clinical Financial Analyst I.
“There’s been a lot of changes in the industry and you want to set a standard for your site, even though some sponsors are setting limits,” Adam explained.
In order to maximize your budget, Joey advised being prudent and methodical in your approach.
“The first and foremost thing you want to understand are the protocol requirements, prior to the budget evaluation. When you get the CTA and the budget, you want to start cranking away your values but you should think about opening that protocol instead and really start digging deep, making sure you understand what the entire study is going to entail,” Joey explained.
A strategy to consider is outlining specific budget line items to prevent unforeseen expenses, particularly when it comes to site preparations:
- Will you need to upgrade current equipment such as freezers and/or purchase new equipment? Ensure you have the proper hardware to conduct the study.
- Will staff need specific training on EDC (electronic data capture) systems? Remember, no two are
ever the same so budget adequately to cover proper training expenses. - Will you be able to meet enrollment goals? Evaluate your patient database, reviewing the I & E
criteria to avoid issues of patient disqualification.
“Do your due diligence for the sponsor/CRO so you can take on studies and manage
them completely and cost effectively,” said Joey. “Get your preparations in place and
then develop the budget.”
It is important for sites to:
- Record the cost of each procedure.
- Log and track costs from study to study so you can compare and understand the range.
- Recognize the time and effort each procedure takes.
- Understand the therapeutic areas of study you’re most familiar with in order to leverage your experience.
- Plan for costs of unforeseen expenses, “…the types of expenses that happen all the time in studies
but they aren’t necessarily procedure specific,” Joey explained.
These expenses can include but are not limited to fees for coordinators, investigators, sub-investigators, subcontracted nurses, other specialists and physicians and third-party vendors such as sleep labs and imaging facilities.
“Shop around. Get the best price and rate you possibly can. Let the sponsor know you’re doing this because you’re demonstrating you’re working to keep costs down,” said Joey.
Another huge unforeseen expense can be data entry. Whether it’s a screening or baseline visit or a safety follow up, it takes time away from in-house staff tasked with other duties that generate greater revenue for the site. “That’s money lost when time is lost with that type of work,” Joey said. Storing data, whether it’s paper or digital, can be a requirement of sponsor/CROs and timelines can run from 15 to 25 years. Whether it’s stored in a closet, a cloud or is part of your CTMS, account for this in the budget.
“Be aggressive and be reasonable at the same time. Think about your site’s therapeutic expertise. If you don’t need a lot of training, you’re bringing assurance to the sponsor. Recognize the value of your established patient database. It’s worth its weight in gold to the sponsor when there’s less advertising needed,” Joey remarked.
Adam added “If you’re in a geographic area that’s attractive to the sponsor/CRO for a given indication in their clinical trial, they’ll recognize you’ll be able to fill a study quickly.”
Demonstrate your reliability by employing good follow-up practices, reaching out regularly, every one to two days. The sponsor/CRO has deadlines to meet. Prompt study implementation, meeting enrollment goals rapidly and being accountable will impress upon the sponsor/CRO that it’s to their advantage to retain your services.
“The accuracy of your work, clean data and the timely submission of documentation are all reassuring to the sponsor,” said Joey.
Part 2 of this series to follow.
