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Services

Overview

The Pediatric Clinical Research Program is designed to handle multiple research studies 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 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
  • Refer for 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
  • Monitor and improve clinical research compliance

Administrative Support

  • Financial oversight of clinical research accounts and activities

Study Coordination

The program is staffed by highly trained, competent, and experienced research coordinators

  • 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
  • Bio-sample processing, storage, and shipping

Last updated: 03/12/2014
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