Clinical Research Program

The Pediatric Clinical Research Coordination Program provides Department of Pediatrics faculty and staff with comprehensive support to conduct clinical research studies at the University of Wisconsin. We have extensive experience in all areas of pharmaceutical research, PI-initiated research, and registries in all pediatric specialties.

Program Objectives

Our program is designed to handle multiple research studies simultaneously, to meet enrollment goals and to facilitate rapid budget and contract turnaround to promote timely study initiation. Overall objectives include:

  • Coordinate all aspects of research studies, including multi-center trials and investigator-initiated research;
  • Provide administrative, regulatory, and operational support to investigators to promote study initiation and implementation;
  • Support outcomes and disease management research;
  • Implement translational research projects; and
  • Refer and facilitate biostatistics support with the Department of Biostatistics and Medical Informatics for clinical research for safety (DSMB) and endpoint analysis.

Services

Regulatory Support

  • Assist with all types of IRB submissions
  • Maintain all sponsor and FDA regulatory documentation
  • Monitor and improve clinical research compliance

Administrative Support

  • Financial oversight of clinical research accounts and activities

Study Coordination

  • Provide inpatient and outpatient coordination of research studies (very limited weekend and holiday coverage)
  • Recruitment of eligible subjects
  • Comprehensive subject follow-up
  • Timely data entry and query resolution
  • Biosample processing, storage, and shipping