Applying To Conduct A Clinical Trial

The clinical trials application process requires a meticulous approach to best navigate varying regulatory environments and meet IND submission criteria. IND-enabling studies are the foundation of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials.

Creating realistic expectations for regulatory considerations, necessary materials for IND submission, and approval timelines early in development is essential for reaching milestones in your IND program on-time and within budget. This series on IND-enabling studies begins with responses to some of the most commonly asked questions that our experts receive from our new clients working on IND program in the small molecule modality.