We Are Early Phase

Focussed on perfect solutions

Each clinical trial brings new challenges and has to be seen from an individual perspective. The staff of CRS’s clinical pharmacological units (CPUs) dedicated itself to respond to these challenges for more than 40 years.

Since 40 Years we tackle any type of clinical pharmacological trial

Besides the standard performance of human pharmacology trials, each of the units has developed its own special expertise based on different clients’ needs and requirements.

  • The division of the corporate structure into six professional Early Phase Clinical Research Units staffed by well-trained personnel has several advantages:
  • Variable trial designs
  • The possibility of splitting large trials (mono- or multi-centric)
  • Decentralised subject recruitment
  • Central modular services for all locations

In order to maximise quality, each unit of CRS operates to a centralised common standard operating procedure (SOP) and a total quality management system (TQM). This enables us to split up very large trials and allows the decentralised, parallel screening and recruitment of healthy volunteers and patients.

Accomodation

Each clinic provides accommodation of hospital or hotel standard for volunteers and patients.

It is combined with spacious lounges (including libraries, televisions and video projectors with a 5.1 sound system), Internet and quality cuisine to make participants feel as comfortable as possible. The arrangement of different wards and lounges in all units allows separation between patients and healthy volunteers as well as between patients of different age groups. Standardised meals are freshly prepared by trained CRS chefs or delivered by external catering services. Special dietary needs (especially in connection with pharmacokinetic profile days, food-drug interaction studies and the long-term nutrition of hospitalised subjects) can be easily met without affecting laboratory parameters.

Volunteer/Patient Panel

CRS constantly recruits new healthy volunteers and patients to ensure wide variety of subjects for its clients.

CRS currently has more than 50,000 volunteers on its books. In addition, it has access to volunteers with symptoms, including allergic, hypertensive and hyperlipidemic subjects. Special panels of genotyped subjects such as poor metabolizers (PM) for a certain cytochrome isoenzyme are also available.
CRS has access to various panels of healthy subjects, healthy subpopulations and patients.

Special Populations

We are able to recruit special healthy populations to special patient populations of all ages.

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 of these 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 Populations

  • Renal & Hepatic: Performing clinical trials in patients with renal or hepatic insufficiency is the core competence of CRS’s clinical pharmacology unit (CPU) in Kiel. Since 1986, Dr Atef Halabi, Medical Director in Kiel, has conducted more than 250 clinical trials in special populations such as patients with, e.g., cirrhosis, renal impairment, and diabetes. CRS’s recruitment success is based on long-term cooperation with specialists since the early 1990s. The CRS network covers, among others, a large hepatology outpatient department, specialists at the university hospital in Kiel, and nephrological dialysis and gastroenterological centers. Since 2009, renal and hepatic 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.
  • Dermatology: CRS’s CPU Kiel has also conducted several studies involving patients with dermatological diseases. These especially include populations with psoriasis, atopic dermatitis, and allergies, among others. A CRS psoriasis panel has been established for first-in-patient (FiP) and pharmacodynamic (PD)-related clinical trials with new chemical and biological entities.
  • 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.

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