Building Your Early Phase Clinical Data From Protocol To Regulatory Submission

Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.

In this article, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.