Case Study 3:
The "First Patient In" Challenge
Creative Problem-Solving & Logistical Excellence
Situation: I was overseeing a rare disease study when we hit a "study-killer" roadblock. During start-up, we discovered that none of our selected investigative sites had access to a critical piece of diagnostic equipment that was mandatory per the protocol. The entire study in our country was at risk.
My Approach:
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Diagnosis: I confirmed the scale of the problem and found there was only one eligible facility with this specialized equipment in the entire country.
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The Challenge: This single facility was thousands of kilometers from our main site. The first potential patient lived over 2,000 km from their site and 3,000 km from the new diagnostic center.
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Systemic Solution: This was no longer just a "site" problem; it was a complex logistics, contracts, and travel problem . I immediately brought together a "solution team" with leads from feasibility, logistics, and contracts to map out a cross-functional plan.
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Execution: We worked in parallel. The contracts team drafted new agreements with the diagnostic facility in record time. Simultaneously, the logistics team and I planned the entire patient journey—including flights, hotels, and ground transport for the patient and their caregiver.
Result: The plan worked. We successfully coordinated all moving parts and screened the first patient. Despite these incredible odds, our country became the first to enroll a patient globally for the entire study.