Laboratory Operations Unit

The LOU leads the development, implementation and evaluation of the laboratory research essential to the successful execution of the IDCRC research agenda. The LOU:

• Facilitates linkage to the VTEUs to select and provide laboratory services for studies
• Implements the sharing and distribution of samples and study-related laboratory data across the IDCRC and approved outside partners and provide quality control and quality assurance of the LOU services provided to the IDCRC
• Develops and implements ancillary studies to support IDCRC clinical research

The LOU is designed to fully manage and oversee relevant laboratory services, such as:

• PK assessments in Phase 1 first-in-human studies and population PK studies, bioanalyses, and specimen characterization
• laboratory quality management programs
• the monitoring and evaluation of all specialized laboratories under the IDCRC
• sharing of specimens outside the IDCRC, as necessary
• providing adequate storage facilities needed to accomplish the IDCRC’s clinical research agenda

The LOU leadership fosters collaboration and harmonization of laboratory activities within the IDCRC and the VTEU-identified laboratories. Finally, the LOU also works with NIAID staff, and NIAID-provided research support programs.