TRIAL RESCUE · RENAL TRANSPLANTATION

The sites weren't failing. The support around them was.

Illustrative image of an experienced research nurse coaching a colleague at a clinic workstation

A global sponsor's Phase IV transplant study was stalling under its original CRO. The reflex is to add sites or amend the protocol. We did neither, because neither was the problem.

The investigators were running competing trials across unrelated indications and were out of hours. Several of their research nurses had never carried multiple enrolling studies at once, so this one kept sliding down the pile. That isn't a motivation problem. Nothing in the setup made it anyone's job to notice, and none of it shows up in a monthly enrollment report.

We took over delivery, repaired the sponsor-investigator relationship that had frayed, and put hands-on coaching and practical support around the research nurses so they could carry this study alongside everything else. Enrollment recovered on the sites and the protocol already in place.

Result: a stalled study back on track, without adding a single site or amending the protocol.

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