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Case Studies

Providing Exceptional Efficiencies by Re-Thinking a Development Plan

Challenge

A client contacted us to conduct a 200-patient cardiovascular trial. The inVentiv Clinical team reviewing the protocol discovered that a simple redesign of the study, specifically the size of the patient population, could create great efficiencies for the client while still providing the necessary information needed for the FDA.

Solution

After a thorough review of the protocol and some preliminary statistical work, inVentiv Clinical found that only 30 patients were needed to generate the necessary data. The team brought their findings to the client's attention and was able to work with their statistical team to come up with a more appropriate and cost effective patient population size.

Outcome

The study was redesigned with an 85% reduction in the number of patients, saving the client substantial time and resources.
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