Addressing the True Cost of Clinical Trial Agreement Delays

When it comes to clinical trials, we all know the uncomfortable truth: no contracts, no cures. It’s that simple, and it’s that frustrating.

Last week, I had the privilege of joining Catherine Gregor from Florence Healthcare and Tara Rabe from Mayo Clinic for a webinar that tackled one of our industry’s most persistent challenges. What emerged was a story that perfectly captures both the problem we’re facing and the transformative potential of purposeful AI implementation and a commitment to process improvement.

The Stark Reality of Clinical Trial Contracting

The numbers tell a sobering story. Recent industry reports show that clinical trial agreements now take an average of over 90 days to negotiate—up from just over 60 days a few years ago. When you consider that these agreements rank alongside complex energy contracts for the slowest contract negotiations you begin to understand the scope of the challenge we’re confronting.

As Catherine pointed out during our discussion, “We have patients waiting to go on trial. We know we need to move faster, but we know we don’t have the resources to do it ….” This resource constraint, particularly with recent HHS cuts affecting administrative roles at academic medical centers, means the problem isn’t just persistent—it’s getting worse.

For Mayo Clinic, this reality was particularly acute. Tara Rabe’s team manages a staggering 6,500 research agreements annually with an approximate 20-person team. When she joined our webinar, she shared something that took remarkable courage: “There was a time where it would take us six to nine months to negotiate a clinical trial agreement, and that’s embarrassing to say the least.”

But here’s what makes Tara’s story extraordinary—and why it offers hope for the entire industry.

The Foundation: Process Before Technology

Before Mayo Clinic implemented any AI solution, they did something essential that too many organizations skip: they fixed their fundamental processes. This wasn’t about throwing technology at a problem; it was about creating the foundation for technology to succeed.

Tara’s team broke down the silos between IRB, budget, and contracting teams, moving from sequential to parallel processing. They implemented master agreements for frequent partners, adopted industry templates like ACTA where possible, and created structured study kickoff processes with agreed-upon timelines.

As Tara emphasized, “You cannot automate a broken process. Automating a broken process is just not going to work.” This insight alone should be framed in every operations office across our industry.

Purpose-Built AI: Beyond Generic Solution

When Mayo Clinic was ready for AI, they didn’t settle for generic tools. They collaborated with us at The Contract Network because they needed purpose-built AI that understands the nuances of research agreements—the difference between subject injury and indemnification, the distinction between publication rights and publicity clauses.

“Clinical trial agreements are the agreements that still take the most time, which kind of blows my mind because it’s still the same terms in every agreement”, shared Tara. The fastest way to negotiate any agreement is to identify whether you’ve done it before, which becomes challenging when you’re managing thousands of agreements with a large team. The solution we created addresses the complete negotiation lifecycle using AI to instantly compare new agreements against previously negotiated templates, providing immediate precedent identification.

For genuinely new agreements, the system analyzes hundreds of potential issues for clinical trial sites, provides compliance alignment summaries, and then generates first-draft AI markups for the negotiation team’s review in minutes. This isn’t about replacing human expertise—it’s about giving negotiators a comprehensive head start.

The Human Element: Trust Through Transparency

One of the most valuable aspects of our discussion was Tara’s candid acknowledgment of team concerns about AI implementation. “I think there was, ‘I’m going to lose my job. This AI is going to take over my job. Can we trust it? How can it do a better job than I can?’”

The solution wasn’t to dismiss these concerns, but to demonstrate value through transparency. The system we built shows exactly what issues it identifies and why, creating opportunities for learning and validation rather than replacement. Within four months of implementation, 71% of Mayo’s staff reported one to three hours of time savings per agreement.

Even more impressive: for certain agreement types like CDAs, the team now requires minimal human touch beyond responsible review. As Tara noted, they’ve reached the point where “with NDAs, we’re running those without any human markups or touches as we’re running them through TCN.”

The Ultimate Measure: Patient Impact

But perhaps the most powerful moment of our webinar came when Tara shared an email from investigators who were able to enroll a patient in a study that offered life-changing opportunities otherwise unavailable. “This is really my ‘why’ of why I come to work every day,” she said, her voice carrying the emotion that drives all of us in this field.

This is what transformation looks like: from six to nine months down to weeks. From administrative burden to patient opportunity. From process frustration to purposeful acceleration.

Moving Forward Together

Mayo Clinic’s journey offers a roadmap for the entire industry. Start with process optimization, implement purpose-built solutions, maintain human oversight, and never lose sight of the patients waiting for the therapies we’re all working to deliver.

The technology exists. The processes can be optimized. The question isn’t whether we can accelerate clinical trial contracting—together, we’ve proven we can. The question is how quickly we can scale this transformation across our entire industry.

Because at the end of the day, when it comes to contracts for cures, every day matters. If you’re ready to reduce delays, support your teams, and accelerate access to life-changing treatments, contact us to see how The Contract Network can help.