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Issue Resolution in Clinical Partnerships
Session Chair(s)
Susan Shelby, PhD
Vice President, Clinical Operations
Biomedical Systems, United States
For each clinical trial, a hierarchy of issue escalation exists among the various vendors and within the sponsor organization. This forum includes representatives from a CRO, a biotechnology company sponsor, a pharmaceutical company sponsor, and a core laboratory executive to define how to best escalate study issues within their environments.
Learning Objective : Clarify who is in the issue escalation pathway; Apply the project management triangle to resolve which issues to escalate; Apply an issue escalation plan.
Speaker(s)
Panelist
Susan Shelby, PhD
Biomedical Systems, United States
Vice President, Clinical Operations
Panelist
Karen Ventrella, RAC
Vertex Pharmaceuticals, United States
Director, Clinical Operations
Panelist
John Mann, MS, PMP
PRA Health Sciences, United States
VP, Project Management, Americas
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