Navigating the Complex World of Clinical Trial Contracts

Following October's COG Europe meeting Pharmaceutical Business Conference Group's Head of Content sat down with Myrthe Trompert to learn more on the subject she presented at the meeting.

David: I'm here today with Myrthe Trompert, CEO of Salvius Legal, to discuss the critical role contracts play in clinical trials. Myrthe, why are clinical trial contracts so important?

Myrthe: Clinical trial contracts establish the compliance, performance, control, timelines, and budget for studies involving various parties like sponsors, CROs, vendors, and investigator sites. Without proper management of your clinical study contracts, clinical trials are at risk of delays, budget issues, and even compliance violations.

David: What makes clinical trial contracting uniquely challenging?

Myrthe: Site contracting in particular poses some key difficulties. The highly regulated nature of trials, country-specific requirements, and overall inefficient contracting processes create hurdles. And when clinical study contracts are delayed, including site contracts, such delays can cause treatments to reach patients later than necessary. In addition, it can significantly increase costs - to the tune of around €1M per day by some estimates.

David: That's a huge number! What does it take to successfully navigate site contracting?

Myrthe: It requires a four-pronged approach: understanding industry standards, excellent drafting and negotiating skills, in-depth knowledge of international and country-specific laws and regulations, and tight process control. Sponsors need experienced teams to craft agreements that are clear, pragmatic, and focused on collaboration between parties. Templates, tracking tools, and risk assessments are also critical.

David: And how should sponsors approach the negotiation process?

Myrthe: The key is balancing assertiveness with an openness to find win-win solutions. Draw clear lines on dealbreakers but don't let negotiations drag on endlessly over minor issues. Keeping the end goals of patient treatment and collaborative partnerships in mind is crucial.

David: It's clear that expertise and the right mindset are must-haves. Any final advice for sponsors embarking on clinical trial contracting?

Myrthe: Investing significant time upfront in solid agreements lays the necessary groundwork for successful studies down the line. So while the contracting process can seem tedious, it's an essential ingredient for getting those critical new therapies to patients.

David: Excellent insights, Myrthe. Thank you for sharing your extensive knowledge on clinical trial contracting with our readers today!

Want to learn more? The Salvius Legal team will be at the next COG Europe meeting in November 2024, as well as COG Nordics held in April 2024.