Datasheet | February 13, 2012

Special Populations: Renal And Hepatic Impairment Datasheet

Source: ICON

ICON’s experience supporting early phase studies in subjects with renal and hepatic impairment, as well as our close contact with local IRBs, allows our team to expedite study start-up project activities and meet enrollment objectives. In addition to our Clinical Pharmacology Units, ICON has collaborated with additional sites with whom we have successfully executed previous renal and hepatic impairment studies.

Recruitment Strategy
ICON’s CPUs enroll these special populations using our robust database, which contains volunteers with renal and hepatic impairment. In addition, we regularly access special populations through our relationships with local physicians. Recognizing that the foundation for a successful study begins with successful recruitment, all our units have a dedicated team whose sole focus is recruiting and screening, regularly employing ongoing and study-specific media campaigns to enhance our ever-growing network of volunteers.

Study Experience
In the past five years, ICON has provided services for over 25 studies involving renal and/or hepatic impairment. This includes:

  • Phase 1 multi-site study in hepatic patients
  • Phase 2 multi-site studies in hepatic patients
  • Renal and Hepatic Study program PK reports & regulatory consulting
  • Hypertension study in hemodialysis patients: protocol development, clinical management and monitoring of proof of concept study
  • Renal program for patients with incontinence: regulatory strategy, PK and Population PK analyses, NDA consulting, In Vitro–In Vivo Correlation study
  • Renal program: PK analysis
  • Combined drug/catheter study: Protocol development and intensive monitoring of single site 30 patients
  • Patients with severe chronic renal failure undergoing dialysis: Phase II 12-site study, Medical monitoring and SAE reporting