The UW Clinical Research Office Regulatory Support unit is a centralized resource offering comprehensive regulatory support services to researchers conducting clinical trials at UW-Madison, UW School of Medicine and Public Health, and UW Health. Regulatory Coordinators aid researchers, research teams, and industry sponsors by delivering enterprise-wide regulatory support, standards, and common infrastructure.
CRO Regulatory Coordinators have experience with clinical trials of all phases from multiple disciplines and departments in both pediatric and adult populations. They prepare and manage clinical research applications for hundreds of individual protocols from single site to multi-center oversight projects including sponsored and investigator-initiated clinical trials, NIH-funded Single IRB (sIRB) projects and ceding requests.
CRO Regulatory Coordinators steer the clinical research applications through regulatory committee reviews and assist in all aspects until IRB or other approvals are received. They work closely with researchers, clinical research coordinators, financial personnel, and departmental personnel to assure an accurate, complete, and comprehensive submission. CRO Regulatory Coordinators are professional, knowledgeable, organized, and highly skilled and boast a collective 80+ years of research regulatory experience. Our research professionals are skilled in translating and interpreting complex research protocols into plain language that can be understood by a lay audience. Expert staff provide the following, but not limited to, services (as applicable):
CRO Regulatory Coordinators also possess special expertise in compassionate use, emergent, and expanded access program applications to the Food and Drug Administration (FDA) and IRB and serve as a liaison with other institutional resources such as the UW Pharmacy, Pharmaceutical Resource Center (PRC), and Research and Sponsored Programs.
CRO Regulatory Coordinators training and certification include:
CRO Regulatory Coordinators concentrate on clinical research applications for submissions to entities such as: