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Services

Overview

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

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