Close the Loop: How Relationship‑Driven Monitoring Improves Effectiveness from Study Start‑Up Through Execution

About this session

This session presents a relationship‑driven approach to monitoring effectiveness that begins during study start‑up and extends through active study execution. Rather than viewing monitoring as a series of site visits, the presentation reframes effectiveness as the result of clear expectations, consistent communication, and strong working relationships established early with investigative sites.

Drawing from real‑world experience supporting complex IDE study start‑up, this session demonstrates how proactive engagement during site activation, structured between‑visit follow‑up, and intentional escalation pathways directly influence monitoring outcomes, action‑item closure, and inspection readiness. The presentation highlights how CRAs can use cadence, trust, and focused performance indicators to reduce recurring issues without increasing operational burden.

Attendees will learn practical ways to organize follow‑up, keep sites engaged, and manage open issues without adding extra work. The session will provide simple tools that CRAs can adapt to their own studies to support timely issue resolution, stronger site relationships, and more effective monitoring over the life of a trial.

Speaker

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  Shanell Laner

  Senior Staff Clinical Research Associate · Stryker

  Speaker