Clinical Research Service Center
The Clinical Research Service Center (CRSC) at IBio supports translational sciences and clinical trials for both pediatric and adult research and includes 4 exam rooms, 2 observation rooms, 2 community outreach conference rooms, 1 specimen processing/shipping laboratory, a research pharmacy, 1 metabolic assessment room and a data storage area that meets both FDA and NIH requirements.
Exam rooms are equipped with beds, exam tables and infusion chairs. The Metabolic Assessment Room is equipped with the Parvo Medics TrueOne 2400 metabolic measurement system. The TruOne 2400 is an integrated system that has the capability to perform cardiopulmonary stress testing, indirect calorimetry, and measurement of maximal oxygen consumption (VO2max). The TrueOne system has the capability to interface and control a TrackMaster TMX428 treadmill and Corival Lode cycle ergometer, allowing automated testing of participants with standard or customized exercise protocols. The system is also outfitted with a 12-lead ECG, and the capacity to assess pulmonary function through measurements of spirometry including maximal voluntary ventilation and residual volume.
The space is designed to conduct all facets of clinical research studies, drug studies inclusive of phase 1 pharmacokinetic studies, outpatient follow up visits, community engagement research as well as behavioral studies. It is designed to facilitate physical exams, as well as interviews, a pharmacy storage and dispensing facility, an additional blood draw and a specimen processing laboratory. In addition, the CRSC has an operation center that consists of 1,636 sq. ft. This space consists of offices and 24 desk spaces with integrated university support services including epidemiology, study design and biostatistics.
The CRSC is a service-based entity designed to facilitate and promote inter disciplinary research. As such it is staffed with physicians, research nurses, study coordinators, regulatory coordinators, a nurse manager, grants management experts, a CRSC Director, a Community Outreach Director and a Medical/Program Director. The research staff can conduct all aspects of clinical research including clinical assessments (blood pressure, measurements, height, weight, etc.), data collection, assistance with preparation and maintenance of IRB documents, and regulatory and document management. The CRSC uses the OnCore enterprise platform for clinical trail management. The OnCore platform interfaces to a Biospecimen Bank housed at IBio (dedicated space for 50 -80°C freezers) that focuses on samples from specific cohorts tied into thematic areas and clinical service lines identified as priority areas for the university.
Forte OnCore Clinical Trial Data Management System - The CRSC uses the FORTE enterprise software to manage all aspects of the clinical research study. It has the ability to manage finance, regulatory and patient data. The OnCore Clinical Trial Data Management System (Forte Research, Madison, WI), has been in use at Wayne State University for cancer-related studies since 2006, and for non-cancer studies since 2010. The OnCore System is utilized by institutions throughout the United States for clinical trial data management, including over one-third of the NCI Comprehensive Cancer Centers. The OnCore System is linked to a Biorepository module for collection, storage, and tracking of samples, and integration with clinical data, including the option for high throughput genomic analysis. The OnCore System is internet accessible and structured for conduct of multiinstitutional studies, including regulatory, enrollment, randomization, and study status for individual subjects at each institution, consistent with privacy and HIPAA regulations and guidelines.
Research Laboratory - The CRSC research laboratory is housed within the IBio building. This is ideal as the entire building is on dual power supply and a backup generator. The laboratory has the following dedicated equipment: 1 refrigerated centrifuge, 2 refrigerators, 6 -80 ºC freezer as well as a specimen repository. The laboratory has the ability to bar code and store samples in the unit's freezers. Specimens can be stored and shipped as required by protocol.
Clinical Laboratory - The DMC/University Laboratories service provides a full range of routine and special diagnostic services 24 hours/day, 7 days/week. The laboratory is fully licensed and provides routine laboratory services required for safety monitoring during clinical trials. The laboratory provides services at discount rates for approved clinical research protocols.
Pharmacy - The Investigational Drug Service (IDS) maintained at the WSU CRSC is staffed by a pharmacist with oversight maintained by Dr. Levy. The WSU CRSC pharmacy is responsible for all investigational drugs dispensed and administered in the unit. It is responsible for secure storage of all investigational drugs; maintenance of all records, inventory logs, and randomization codes; preparation and dispensing of investigational drugs upon order of the responsible investigator; and quality control of all investigational drugs.
Computers - The CRSC has 8 Windows based PC, 5 printer/scanners/faxes and 1 network printer/photocopy/fax machine. The CRSC owns a variety of software applications for word processing, data management, spreadsheet, graphics, pharmacokinetic/pharmacodynamic modeling, statistics and communications. In addition, each investigator has access to the Wayne State University Computing Servicesfacility, which maintains full mainframe capabilities for data management, statistics, and graphics.
Echocardiography Core Lab - The CRSC currently has one state of the art GoldSeal Vivid q BT11 echocardiography machine from General Electric. All echocardiographs are acquired at point-of-care in the CRSC by a board certified ultrasound technician and scans are interpreted in the Core Lab using a dedicated EchoPak workstation.