The Office of Research Regulatory Affairs (ORRA)
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 and treat pediatric illness. With the guidance and support of the Office of Research Regulatory Affairs (ORRA) investigators, programs and medical faculty and staff are equipped to navigate the complex regulatory landscape, develop regulatory strategy and move new ideas into clinical trials.
The ORRA also services both Nationwide Children’s Hospital and the Abigail Wexner Research Institute by:
- Providing guidance on emergent regulatory issues,
- Spearheading data quality and integrity programs for preclinical research, and
- Advising partners such as the Institutional Review Board, Institutional Animal Care and Use Committee, Legal Services, Office of Research Compliance and Integrity, Clinical Research
Services and More
ORRA staff maintain broad regulatory expertise to create a detailed strategy for our clients and aid in successful FDA reviews. Our team focuses 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