In Vitro Diagnostics Development and Clinical Trials Group offers integrated services for every stage of clinical research — from development to commercialization. A results-driven academic enterprise, this group provides professional clinical laboratory medicine expertise for the laboratory diagnostics industry. The group’s clinical footprint and centralized laboratories affords near limitless resources for the evaluation of developing clinical laboratory technologies.
The In Vitro Diagnostics Development and Clinical Trials Group team evaluates new in vitro diagnostic (IVD) devices or assays by comparison to conventional laboratory testing and/or similar molecular or analytic tests. Available services include reproducibility/precision testing, access to banks of clinical samples/tissue/microorganisms for the evaluation of new technologies, assays, antimicrobials and detection/identification systems. The research team is comprised of personnel that are certified medical technologists as well as certified clinical research coordinators by ACRP/SOCRA with many years’ experience in all phases and processes for conducting clinical research (GCPs, IRB submissions, contract negotiations).
The In Vitro Diagnostics Development and Clinical Trials Group is actively involved with numerous corporations/investigators in the development of new technologies (alpha, beta, pre-clinical & investigator-initiated studies), collaborating with industrial and academic organizations on any phase of the developmental research and clinical trial process, including expert review of biopsy histopathology or cytology.
Indiana University School of Medicine is recognized nationally as a center of excellence in patient care, physician training and research. Located in the heart of Indianapolis, the IU School of Medicine is a part of the IU Indianapolis campus. The IU School of Medicine staff service four-core hospitals in downtown Indianapolis, including IU Health University Hospital, IU Health Methodist Hospital, Eskenazi Health Sidney & Lois Eskenazi Hospital and Riley Children’s Hospital.
Indiana University Health includes Indiana’s most comprehensive academic health center and is one of the busiest hospital systems in the United States. The IU Health system includes 20 hospitals, 65 outpatient clinics and over 100 primary care clinics across Indiana, with over 117,245 admission and 2.5 million outpatients’ visits annually. IU School of Medicine and IU Health Physicians provide care centered at the academic health center in Indianapolis (Methodist, University and Riley Hospitals).
IU Health’s Pathology Lab offers some of the most comprehensive laboratory services in Indiana. Open 24 hours a day, seven days a week, the laboratories perform more than 19 million tests a year. In addition to IU Health, laboratory-testing services are provided to hospitals and physicians across the country.
Eskenazi Health serves as the public hospital division of the Health & Hospital Corporation of Marion County. Most physicians are IU School of Medicine faculty and provide a comprehensive range of primary and specialty care services at the 315-bed hospital and outpatient facilities both on and off the Eskenazi Health main campus as well as at ten Eskenazi Health locations throughout Indianapolis.
Address and Contact Information
IU School of Medicine Clinical Trials
IU Health University Hospital
550 University Blvd.
AOC 6th Floor Room 6029
Indianapolis, IN 46202
317-274-3392
Rebecca Buckner, M(ASCP), CCRC — Clinical Research Operations Manager
Office: 317-274-3389
Cell: 317-374-4533
Fax: 317-274-3038
rbuckner@iu.edu
Del Warren, MLS (ASCP)CM — Clinical Research Business Manager
Office: 317-274-1734
deawarre@iu.edu