The Institutional Office of Regulated Nonclinical Studies (ORNcS) conducts regulated studies in coordination with UTMB faculty members who are working on contracted studies that require Quality Systems, such as those described in the FDA Good Laboratory Practice regulations (21 CFR Part 58). The ORNcS, established under the direction of the Executive Vice President and Provost/Dean of the School of Medicine, provides the regulatory infrastructure to support regulated studies performed under Quality Management Systems (QMS) utilizing the GLP regulations as a reference standard. The office partners with scientific teams to provide regulatory strategy to facilitate licensure and documentation for development of new drugs and biologics.
The ORNcS contains a scientific, regulatory affairs branch and a regulatory operations branch that operate in parallel to support the conduct and oversight of regulated studies. The scientific branch provides oversight for the planning and conduct of regulated studies under the direction of a Study Director.
The regulatory compliance branch provides regulatory oversight via independent Quality Assurance Unit (QAU) inspections along with document control and retention capabilities. An administrative team allows for the execution of contracts in coordination with UTMB’s Technology Transfer office and grant’s management office.
Project milestones and contract deliverables are negotiated through the ORNcS in coordination with appropriate scientific subject matter experts. Execution of the study is performed under the direction of an ORNcS Study Director and in compliance with the study protocol and standardized laboratory procedures. ORNcS personal involved in the conduct and regulatory oversight of adequate and well controlled studies are charged as a percent of their effort for the project.
Note: Website text is not intended for inclusion in proposal submissions. Please contact our office for language that may be incorporated into proposal submissions.
Institutional Office of Regulated Nonclinical Studies
University of Texas Medical Branch at Galveston
2.810 Rebecca Sealy, Route 0184
301 University Blvd.
Galveston, TX 77555
Phone: (409) 747.8138
ORNcS Collaborative Partners: