Perfecting Phase 2: 10 Essential Steps for Individualizing Clinical Development

 

Utilizing commodity clinical development services in phase 2 is a recipe for disaster. The key to phase 2 success is individualizing every aspect of each trial to meet the specific requirements of the investigational product. Individualization must address key areas such as ensuring collection of data to support future label statements, defining go/no-go decision criteria, identifying optimal doses for phase 3, identifying satisfactory endpoints to demonstrate clinical benefit, performing protocol feasibility for each study, and balancing the selection of the population for each study with the need to support future product acceptance by a commercially viable market.

Download Perfecting Phase 2 and learn about 10 essential steps for individualizing phase 2 clinical development and increasing your chances of a successful transition to phase 3.

 

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