Special Populations

CRS is able to offer a broad range of special populations in the field of healthy sub-populations as well as special patient populations. Some panels are listed below by way of example.

Special Healthy Populations
  • Senior citizens: CRS has plenty of experience in the recruitment of elderly volunteers and its panel is regularly updated. For one successful clinical trial, elderly subjects had to be recruited who were more than 75 years old and not on any co-medication. An increasing number of studies involving patients from different indication fields also require the recruitment of a substantial number of elderly subjects.
  • Post-menopausal women: In recent years, studies with post-menopausal women have been performed on both inpatients and outpatients. Handling and recruiting post-menopausal women as well as elderly volunteers is part of CRS’s standard routine.
  • Genotyped Subjects: Over 3,000 healthy subjects are genotyped for the cytochrome P450 genes CYP2D6 (> 100 poor metabolizers), CYP2C9 (> 170 PM) and CYP2C19 (> 90 PM). Additional panels such as UGT1A1 characterisation are in preparation.
Special Patient Population
  • Renal & Hepatic: Performing trials in renal and hepatic insufficiency patients is the main expertise of the CPU in Kiel. Since 1986 Dr. Halabi, the medical director in Kiel, has conducted more than 130 trials in special populations such as cirrhosis, renal impairment and diabetes. Recruitment success is based on long-term cooperation with specialists since the early 1990s. The network consists of a large hepatology outpatient department (over 1,000 patients per year), two university hospitals in Schleswig-Holstein, and nephrological dialysis and gastroenterological centres. Since 2009, renal insufficiency trials have also been conducted at CRS’s Mannheim clinic. 
  • COPD/Asthma: Over 25 inhalation studies have been carried out since 2005, most of them with COPD and asthma patients. 
  • Diabetic patients: CRS clinics have access to diabetic patients who have been successfully recruited for trials. CRS-Mannheim has experience of glucose clamp trials. 
  • Male Fertile Subjects: CRS has carried out several fertility trials to measure the spermatogenesis effects of new compounds according to WHO criteria. Usually these kinds of trials require extended screening procedures to select healthy males who meet the criteria specified. 
  • Benign Prostata Hyperplasia: This panel is based on criteria such as testosterone level, bladder and prostate volume, and documented PSA levels for PK & PD trials.
  • Hypogonadism: CRS has experience in recruiting male volunteers with confirmed low testosterone levels to conduct pilot and confirmatory BE trials as well as for PD trials. 
  • Psoriasis: An existing psoriasis panel has been used in the past for first-in-patient and PD-related trials with new chemical and biological entities.