Solutions to the Challenges of Phase I and FIM Studies in Today’s World

This 90-minute webinar will help you identify the challenges in Phase I and FIM studies and present solutions on how to overcome these challenges.

Why Should You Attend:

As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences.

The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and the sites are becoming increasingly important. No longer is the First-in-Man study only done on normal healthy volunteers or are protocols fixed lines in the sand that are not changeable until the study is completed. No longer is the New Chemical Entity (NCE) a simple chemical with almost predictable effects and we no longer see Phase I studies conducted only in confined Clinical Pharmacology Units. All of these challenges make recruiting more challenging and Monitoring equally so.

The answer is to identify the challenges and keep up with the changing environment in the development of these NCE’s in ever more complex and serious diseases so that the DRA’s find nothing to shut you down for. The focus of this 90-minute webinar is how to overcome the challenges in Phase I and FIM studies.