A client engaged Allucent to prepare a food-effect study protocol, analyze interim PK data, and author a clinical information amendment for submission to regulatory authorities. The conduct and reporting of PK results of the food-effect study was on critical path to initiation of a Phase 2 clinical study. The challenge for the client was that the protocol, PK data analysis, and PK clinical information amendment for regulatory submission needed to be prepared in a very short timeframe.
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