Considerations When Planning And Conducting Early Stage Trials

While pivotal clinical trials remain critical to securing the approvals required for the launch of new drugs, it is interesting and also encouraging to observe a common thread running through some recent regulatory and policy discussions.

That theme is ever closer cooperation between industry sponsors and regulatory authorities, particularly in relation to new forms of therapy.

This e-book takes a look at some of the considerations when planning and conducting early stage trials, highlighting several major issues in the space and lessons from changes to regulatory guidance. It also examines the current industry trends for early drug development and market access, especially in Japan where increased incentives and recent reforms have provided new opportunities for pharma in the region.