About Us

Mission Statement

The mission for the University of Texas Medical Branch (UTMB) Office of Regulated Nonclinical Studies (ORNcS) is to provide scientific, regulatory and good laboratory practice support to research and development programs during planning and conduct of in vitro and in vivo nonclinical studies to support licensure.

History

In 2006 the conduct of FDA regulated nonclinical studies were managed by the GLP (Good Laboratory Practice) Program Office, operating within the Research Services office composed of a GLP Program Manager, Quality Assurance Analyst and an archivist. The staff worked to educate faculty and staff and assist in the development of quality systems through organization of GLP working groups and conduct of pre-GLP assessments of study documents. Faculty members conducting non-GLP studies, to be included with regulatory documents submitted by the sponsor in support of investigational new drug (IND) applications, engaged with the GLP Program Office to develop Standard Operating Procedures, personnel training files, data capture forms and equipment maintenance and calibration records. The GLP Program Office gained independence from the Research Services, expanded with addition of a regulatory scientific team to conduct regulated studies and organized them to form the new Institutional Office of Regulated Nonclinical Studies (ORNcS). In 2013, personnel from the Regulatory Core in the Galveston National Laboratory (GNL) were incorporated into the ORNcS.

About Us

ORNcS.Drawing2A regulated study is one which follows a defined set of guidelines and/or rules to ensure data quality and integrity. Regulated studies are conducted in accordance with applicable standards of research and are associated with adequate documentation to confirm the results and meet FDA scrutiny. ORNcS Regulatory Affairs consists of a Managerial and Technical staff with over 40+ years of combined experience in biocontainment (Biological Safety Levels 2, 3, and 4) studies and 13+ years of combined experience in contract work supporting the licensure of medical countermeasures to biological threat agents. In addition to experienced personnel, the ORNcS manages two restricted access BSL-2 laboratories housed in the Galveston National Laboratory that support the conduct of adequate and well controlled studies.

Areas of Expertise (subject to change):
  • Study Design, Conduct and Oversight
  • Technical Training for all personnel
  • Good Laboratory Practice (21 CFR Part 58)
  • Medical Countermeasure Development and Testing
  • US FDA Food and Drug Administration Animal Rule Studies
    (21 CFR Parts 314 and 601)
  • Animal Model Development
  • Bacteriology
  • Virology
  • Mycology
  • Assay Development and Validation
  • Equipment Validation and Calibration
  • Contract Research Organization Experience
  • Academic Experience
  • Audit Preparation and Response
  • Report Writing
  • Consultation

ORNcS.Drawing3Regulatory Operations provides education and consulting to Principal Investigators (PIs) to aid in the establishment of quality system elements (e.g. standard operating procedures, training records, equipment records, etc.) that allow the conduct of studies in accordance with Federal regulations and/or a quality agreement as required by a sponsoring agency. Our staff advises the PI and/or management of potential regulatory/quality agreement gaps and provides independent quality assurance oversight during the conduct of regulated studies. We also organize, index, and archive study documents and host regulatory and sponsor inspections.

We work together with the ORNcS Scientific and Regulatory Affairs branch and PIs to promote data quality and integrity.

Areas of Service:

Document Review for regulatory language and interpretation, including:

    • Proposal Submissions
    • Standard Operating Procedures
    • Equipment/Assay Qualification/Validation Plans

Regulatory Education, including:

    • Good Laboratory Practices
    • Good Documentation Practices
    • Writing Effective Standard Operating Procedures

Quality Assurance Inspections, including:

    • Regulatory Gap Analysis of Laboratories
    • Data Verification (Final Report audit)
    • Facility Inspections
    • Critical Study Phase Inspections

Study Records Archival, including:

    • Organization and Indexing of Study Records
    • Long-term Retention in Secured Archive Facility
    • Document Distribution
    • Electronic Document Management (Master Control Electronic Document Management System)
    • Verification of Electronic Datasets

Other Services, including:

    • Hosting Sponsor and Regulatory Agency Inspections
    • Development of Quality Systems
    • Regulatory Writing
    • Regulatory Consultation