Case Study 1:
Crisis Leadership & Business Continuity
Safeguarding a Trial During the War in Ukraine
Situation: When the war in Ukraine escalated, we faced an immediate crisis. We had several sites impacted, threatening the integrity of our essential documents (Investigator Site Files) and the continuity of our data. The sponsor did not have an emergency archiving vendor in place to manage a collection.
My Approach:
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Proactive Solution: I immediately informed the sponsor of the risk. Since they had no vendor, I proposed we use one of my company's (IQVIA's) pre-approved, audited providers for secure, emergency document collection.
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Rapid Stakeholder Buy-in: I presented a complete logistics plan, capabilities summary, and cost estimate, securing formal sponsor approval within 24 hours.
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Logistics Management: I managed the entire operation, coordinating between this new provider and the local sites. We first moved the files to a temporary secure warehouse in Kyiv. As the situation evolved, I coordinated a second transfer to a long-term, secure facility in Poland, well outside the conflict zone.
Result: We successfully secured 100% of all essential documents with zero data loss. The sponsor formally recognized the team for exceptional risk management and for providing a rapid, effective solution under extreme circumstances.