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10 Steps to Clinical Study Startup: Step 7 - Negotiate the CTA

by Jae Chung

It is rare for an original CTA template to be accepted verbatim by sites when they receive the first draft from the sponsor. This is not a bad thing; quite the contrary – negotiation is important part of the process and should serve to meet the needs of all parties.

10 Steps to Clinical Study Startup: Step 7 - Negotiate the CTA

When negotiating CTAs, you will want to define and rank the interests/needs of the site, as well as, to access the priorities of the other parties such as labs, IRBs, imaging groups etc. It is critical to understand that negotiations are based on different interests of the parties and the likely result will be concessions regarding these interests. Sponsors and sites need to trade items or issues of less importance in order to gain substance of greater importance. The better sponsors and sites understand each other's perspectives, the greater likelihood of successful and timely outcomes.

Common pitfalls

Internal policies restrict your ability to negotiate

If you are a site and have had to pass on multiple contracts due to a single internal policy, it may be a good idea to have a full review of that policy. For example, some sites have such stringent insurance requirements they are precluded from most trials. The solution may be to find an alternate provider.

Restrictive payment terms

Most companies develop payment terms in a 'pay for work as completed' premise, however, there are times when the sites may need payment up front in order to manage/acquire resources to conduct the study. In addition, the concept of Fair Market Value (FMV) has been applied to clinical trial contracts and is a stringent policy, which cannot be overruled by study team members. When it comes to payment terms and monetary reimbursement – if suitable terms are not met the best and only choice may be to walk away, rather than accept a contract, which would be financially unreasonable for the site to perform or outside of FMV. A win-win scenario is what everyone is shooting for and there is no 'win' if the site will lose money to perform a trial.

Keep in mind that you would not be in negotiations in the first place if all parties did not want the same thing – a fully executed agreement outlining mutual involvement in the trial.

Sherry S Kellogg
Regulatory Coordinator
Palm Research Center, Inc
"I encourage sites to focus on the budget and areas that are meaningful to your site's success. Don't be afraid to make bold requests, but know your bottom line and have documentation to support your stance. Knowing your site’s strengths and the finer details of the trial will leverage your budget and help you negotiate unconventional provisions (e.g. monitoring support, regulatory start-up fees, etc.) that are important to your site. Sponsors play hardball when it comes to the budget, but it's hard to argue with facts, so have supportive documentation and know which areas you are willing to bargain on and which areas are nonnegotiable. Protect your interests and reputation, but understand that being flexible is mutually beneficial."

10 Steps in Clinical Study Startup

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