Hepatology

We conduct all kind of trials in this specialty

CRS has considerable expertise and long standing experience in conducting early phase clinical trials involving patients with hepatic impairment. More than 100 such trials have been successfully completed since the early 90s. A track record, that has put CRS among the top contract research organizations (CROs) for the conduct of clinical trials in hepatic impairment, has been recognized by competent authorities.

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

  • Sonography
  • Fibroscan
  • Fibrotest
  • 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

REACHING OUT IS EASY AND FAST – LET’S TALK

Prof. Dr. Thomas Forst

Chief Medical Officer (CMO)
located at CRS Mannheim


LET’S TALK SCIENCE

Dr. Volker Menschik

Chief Business Officer (CBO)
located at CRS Berlin


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CRO Leadership Awards 2019

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

European Biotechnology Guide

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

EcoVadis – CSR Rating

Based on the CSR rating by EcoVadis in July 2018 CRS has been granted Silver Recognition Level.