How To Build Effective Clinical Trial Oversight And Leadership

Biopharmaceutical clinical trial sponsors shoulder both financial and oversight responsibility for their study. While the sponsor’s C-suite usually offers some high-level strategic direction and helps with project resourcing, outsourcing partners typically manage the trial’s operational aspects. But poor vetting, overreliance on partners, and ineffective collaboration can quickly derail a clinical trial. To stay on time and on budget, sponsors must balance mutual trust with productive “pushback.”

In a traditional outsourcing model, the sponsor has limited access to the key individuals working under the CRO project manager. This structure often hides operational issues, as all communication is funneled through the project manager. While many sponsors believe this is what they want— a hands-off approach that still delivers precise data—they overlook the fact that everyone beneath the CRO project manager has direct, critical interactions with the sites generating and managing that data, leaving the sponsor vulnerable.