Negotiating Site/Sponsor Contracts Doesn’t Have to be Adversarial

Molly Huggins, JD, MHA, Partner, Huggins & Zuiker, LLP

Molly Huggins, JD, MHA, Partner, Huggins & Zuiker, LLP

It might sound a little new age-y, but one of the best ways to ensure relatively quick and fair trial agreements between sites and sponsors is to spend a little time walking around in the other side’s moccasins, say two legal experts who’ve helped negotiate agreements from both sides of the table.

“The biggest mistake people make in contract negotiation is not asking the other side what they are worried about,” says Molly Huggins, JD, MHA, a partner with Huggins & Zuiker, LLP, a life sciences law firm. Both sides can save a lot of time, and iron out a more effective agreement, if they have a clear idea of the other party’s mindset.

For example, a sponsor that’s been burned in the past by data entry mistakes or data security issues might zero in on that during a negotiation. To the site, unaware of that history, the sponsor’s actions might feel like overkill. However, a site that directly asks where the motive is coming from can more easily find contract language that addresses the situation without being too broad or cumbersome, Huggins says.

A second mistake is to fall back on standard contract language, says Erin Zuiker, JD, MPH, also a partner with Huggins & Zuiker. As an example, there’s a big difference in contract requirements between a first-time human subject trial versus a retrospective trial project, she notes. Understanding that can get you to the finish line a little faster, she adds.

Make sure you understand the critical legal issues that should be addressed in each of your clinical trial agreements and the suggesting language for addressing their trickier provisions by attending Huggins and Zuiker’s ACRP 2017 Meeting & Expo session, Battle of the Clinical Trial Agreements: Sites vs. Sponsors. View Schedule & Program

It’s also important to remember that sites and sponsors operate under very different regulatory schemes, Huggins explains. Device and drug manufacturers often are more concerned specifically with what the U.S. Food and Drug Administration thinks, while sites may be more fixated on guidance from other agencies of the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services, depending on the nature of the trial.

Huggins has been involved in contract negotiations where the site was pushing for strong Health Insurance Portability and Accountability Act language and the sponsor at first didn’t understand why it was such an important component of the agreement from the site’s perspective. The sponsor understood it better when the site explained how it could lose Medicare financial opportunities, among other important considerations, if it failed to get that part done just right. Reaching that teachable moment enabled the negotiations to proceed with a new momentum.

Author: Michael Causey