Our Clinical Trials Research Program provides faculty and staff with comprehensive support to conduct clinical research studies at the University of Wisconsin.
We are committed to conducting the highest quality clinical research and offering innovative new therapies to our patients, aiming to improve short and long-term patient outcomes. The dedicated clinical research staff has extensive experience in all areas of pharmaceutical and device research including Phase 1 through Phase 4 drug development, compassionate use protocols, investigator held IND studies, bioequivalence and pharmacokinetic studies, and IDE device studies.
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Our Services
The Surgery Clinical Research Program is designed to handle multiple clinical trials simultaneously, to meet and exceed enrollment goals and to facilitate rapid budget and contract turn around to promote timely study initiation.
- Coordinate all aspects of clinical research studies including multi-center trials and investigator-initiated research
- Provide administrative, regulatory, and operational support to investigators to promote rapid study initiation and implementation
- Support outcomes and disease management research
- Implement translational research projects
- Coordinate Phase I/II drug/biologic development trials
- Assist faculty with identifying clinical research opportunities within area of expertise
- Coordinate the Department of Surgery’s clinical research efforts with research sponsors, University of Wisconsin Hospital and Clinics, American Family Children’s Hospital, Meriter Hospital, VA Medical Center, and collaborators in other UW departments and academic centers
- Provide biostatistics support for clinical research for safety (DSMB) and endpoint analysis
Regulatory Support
- Assist with all types of IRB submissions
- Prompt and complete submissions to local and central IRBs
- Maintain all sponsor and FDA regulatory documentation
- Assist with preparation of FDA IND submissions
- Monitor and Improve clinical research compliance
Administrative Support
- Assist Department of Surgery faculty with designing clinical research protocols for investigator-initiated studies
- Provide investigator training and educational opportunities
- Protocol feasibility evaluation
- Clinical trial budget development and negotiation
- Identify new clinical trial opportunities
- Financial oversight of clinical research accounts and activities
Study Coordination
The program is staffed by highly trained, competent, and experienced clinical research coordinators
- Provide inpatient and outpatient coordination of all phases of clinical trials
- Recruitment of eligible subjects
- Comprehensive subject follow up
- Timely data entry and query resolution
- PK/PD sampling capabilities
- Bio-sample collection, processing, storage, and shipping
Clinical Research Facilities
- Office and lab space in Wisconsin Institutes for Medical Research (WIMR) and Clinical Science Center (CSC) which are connected to University of Wisconsin Hospital and Clinics (UWHC), American Family Children’s Hospital (AFCH), UW Health at the American Center (TAC) and the VA Medical Center (VAMC)
- Pharmaceutical Research Center for drug storage, dispensation, and maintenance
- Lab space includes:
- refrigerated centrifuge
- microcentrifuge
- sterile hood
- dry ice
- -80 and -20 degree freezers
- Ample locked storage space for study files
- Conference rooms with wireless internet access for monitoring visits
- On-site phlebotomy and clinical lab services
Clinical Trials Research Program
Contact Us
Surgery Trials
clinicalresearch@surgery.wisc.edu
(608) 262-0540