We conduct all kind of trials in this specialty
CRS – top-level in hepatic impairment clinical trials
CRS, in particular the CRS Kiel unit, currently runs approximately three to five hepatic impairment clinical trials per year with a duration of four to six months each. In recent years, CRS has conducted clinical trials involving patients with hepatic insufficiency, nonalcoholic steatohepatitis (NASH), and liver cirrhosis. Clinical trials with challenging pharmacokinetic (PK) and pharmacodynamic (PD) designs, dose titration, different drug formulations and different routes of administration, as well as blinded and unblinded designs have also been efficiently completed.
Our well-established success in the conduct of hepatic impairment trials is based on the special expertise of the CRS Kiel team and its head, the board certified internist Dr Atef Halabi, Managing & Medical Director CRS Kiel. The broad experience of the team allows CRS to find targeted strategies and tailored design solutions for the fast and successful development of our customers’ products.
CRS Kiel has access to high numbers of suitable patients, thanks to a close and long-standing cooperation with a network of hepatologists, hepatology outpatient clinics, and specialists at the hepatology department of the university hospital in Kiel. The CRS database allows easy identification and rapid recruitment of volunteers, patients, as well as matched elderly controls for all kind of clinical trials in the field of hepatology. All this results in a quick start and timely completion of our trials.
Additionally, the local medical lab partner of CRS Kiel, LKF – Laboratorium für Klinische Forschung GmbH, which is specialized and accredited for the support of clinical trials, secures a reliable and rapid turnaround of laboratory results, most of which will be supplied within six hours. This facilitates screening and review of inclusion/exclusion criteria, as well as close safety monitoring of trial participants.
Hepatic assessment techniques employed at CRS
- Magnetic resonance imaging (MRI) / computerized tomography (CT) imaging (external facilities)
- Child-pugh classification
- MELD-Score (model of end stage liver disease score)
- Number connection test
- Special liver parameters and tests
- Liver check-up test