Moving discoveries from bench to the best outcomes for children everywhere.
The Abigail Wexner Research Institute at Nationwide Children’s Hospital enhances the health of children by engaging in high quality, cutting-edge research that results in better ways to prevent, screen for, diagnose, or treat pediatric diseases. Conducting clinical trials is a key step in translating these lab discoveries into standard clinical practice. The Food and Drug Administration closely regulates human participation in clinical trials involving new drugs and devices. Drug and Device Development Services guides investigators through this complex submission, review and approval process. We provide a streamlined, uniform and consistent approach to development and implementation of clinical trials.
Drug and Device Development Services resides within the Abigail Nationwide Children’s Hospital. Our goal is to help our clients and medical faculty to move new ideas into clinical trials by guiding them through the regulatory landscape. Drug and Device Development Services staff maintain broad regulatory expertise to create a detailed strategy for our clients and aid in successful FDA reviews.
Our services focus on ensuring your success through:
- Knowledgeable guidance and advice
- Early engagement and education to stakeholders
- Ongoing coordination with FDA representatives
- Timely and complete submission of necessary applications
- Careful schedule and budget planning to minimize risk
View or print a fact-sheet with a detailed breakdown of our services.
Please visit this web site often for additional tools, resources and education materials on Investigative New Drug and Investigative Device Exemption applications.