CRS-Group > locations of CRS > Kiel > Specific Expertise
Phase I Clinical Trials
All types of Phase I clinical trials (Dose finding and First in Man studies, Pharmacokinetic and Pharmacodynamic studies, Drug-Drug and Food-Drug Interaction studies, Bioavailability and Bioequivalence studies, in-house long term studies etc.) are conducted at this unit, based on a panel of more than 2000 healthy volunteers.
Special Patient Populations in Phase I/II
Almost 10 years of close cooperation with the University Clinics enables CRS-Kiel to offer clinical Phase I/II studies in several therapeutic areas.
Studies are organised in cooperation with CRS-Kiel and the Kiel University Clinics and conducted within our CRO together with the external specialists in the following therapeutic areas:
- Hepatic Cirrhosis
- Renal Insufficiency
- Hyperlipidaemia
- Diabetes mellitus
- Hypertension
- Dermatological Patients
- Neurological Disorders
- Gynecological Field
Special Volunteer Groups
Frequent studies led to a repeated cooperation with healthy post-menopausal women and healthy elderly volunteers.
365 elderly healthy volunteers, including 150 postmenopausal women
Range of Services
- Dose finding and First in Man studies
- Interaction studies (Drug-Drug and Food-Drug)
- Developing for Transdermal Therapeutic Systems (TTS)
- Pharmacodynamic studies
- Biocompatibility and First-in-Man studies of medicinal products
- Bioavailability and Bioequivalence studies
- In-house long term studies
- Due to our cooperation within the CRS Andernach group, we are able to offer complete trial planning, trial conduction and trial evaluation
Clinical Experience Phase I and Phase II a
| Therapeutic Area | Number of studies | Number of subjects |
|---|---|---|
| Total | 57 | 2180 |
| Cardiovascular | 14 | 382 |
| Endocrinology | 6 | 144 |
| Analgesics/Rheumatology | 5 | 96 |
| Neurology | 5 | 148 |
| Immunology | 3 | 320 |
| Anti-Infectives | 6 | 98 |
| Urology | 2 | 32 |
| Psychopharmacology | 4 | 84 |
| Metabolism | 8 | 196 |
| Labor diagnostic | 4 | 680 |
The following clinical studies in special patient/volunteer populations have been contracted to CRS-Kiel since January 2000:
| Indication/Specification | Number of studies | Number of patients/volunteers |
|---|---|---|
| Total | 56 | 1528 |
| Hepatic cirrhosis | 11 | 252 |
| Renal insufficiency | 15 | 314 |
| Hyperlipidaemia | 4 | 112 |
| Diabetes | 6 | 136 |
| Hypertonia | 6 | 148 |
| Elderly volunteer | 8 | 404 |
| Post-menopausal | 6 | 162 |