Understand The R&D Process

Preparation for Clinical Trials

Testing a therapy candidate in preclinical studies is usually the next step. But if a therapy appears to be both safe and effective in the initial studies, there are actually several other elements that need to be in place prior to moving to clinical trials in humans. In addition to helping fund preclinical studies, your group can choose to be involved in these key areas as a therapy moves forward towards clinical trials. 

Resources

Preparation for Clinical Trials
Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)
Tips to Learn More
How Does FDA Approve a Drug U. S. Food and Drug Administration (FDA) (link)
The Drug Development Process U. S. Food and Drug Administration (FDA) (link)
The Device Development Process U. S. Food and Drug Administration (FDA) (link)
CDER Learn Training and Education U. S. Food and Drug Administration (FDA) (link)
Drug Approval: Bringing a New Drug to the Market U. S. Food and Drug Administration (FDA) (link)
European Patients' Academy European Patients' Academy on Therapeutic Innovation (link)