Drug and Device Development Services

Helping move discoveries from bench to bedside.

The 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.

Services and Goals

Drug and Device Development Services resides within the The Research Institute at Nationwide Children’s Hospital. We exist to help our medical faculty and investigators get from pre-clinical to clinical trials, as well as guide external partners and collaborators through the regulatory landscape.

Our services focus on ensuring your success through:

  • Knowledgeable guidance and advice to stakeholders
  • Early engagement and education of investigators
  • 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.

Useful Links