Comprehensive Preclinical Development Program

By Aptuit, Inc.

The Challenge
Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. As expected with a large program with many "moving" parts, there were many logistical issues in the scheduling. A careful plan for ongoing communications as the project developed was essential in troubleshooting problems as they might arise.