Pharmacology

Assay of PK, PD, BA & BE; clinical evaluation of Biologics

CRS has accomplished hundreds of pharmacological trials in the last 40 years. CRS’s clinical teams are able to handle large-scale trials with high sample sizes of N = 200 ore more, and, moreover, CRS’s resources guarantee the quickest possible performance.

A new pharmaceutical compound has to pass an elaborate and complex trial program before being placed on the market as a pharmaceutical product. In this respect clinical trials are designed to test the safety and tolerability, the pharmacokinetic (PK) and pharmacodynamic (PD) conduct, and the therapeutic action features.

CRS’s trial performance regularly reaches highest ratings in audits and inspections

Overall, clinical trials are strictly regulated to ensure that they follow highest ethical standards and international recognized rules and requirements.

Phase I clinical trials, which follow the preclinical development of a new pharmaceutical compound, represent the first clinical use of the pharmaceutical in humans. In most cases, these First-in-Human (FiH) clinical trials are performed in healthy volunteers. For this, CRS naturally acts on the highest level of care and caution and with long standing experience in the conduct of such clinical trials on all medicinal products – new chemical entity (NCE) just like new biologics.

  • First-in-Human (FiH) clinical trials (single and multiple dose)
  • Drug-drug interaction studies
  • Food-drug interaction studies
  • Bioequivalence (BE) and bioavailability (BA) studies
  • Clinical trials in specific populations (e.g., renal impairment, hepatic impairment, age, gender)
  • Thorough QT/QTc (TQT) studies.

Our well equipped clinical sites, together with our highly educated and experienced staff guarantee the generation of high quality controlled and validated trial results.

In 2008, 2009, 2010, 2011 and 2014, the U.S. Food and Drug Administration (FDA) performed inspections of bioequivalence studies performed by CRS and awarded the highest rating in all cases: ‘No Action Indicated’.

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


LET’S TALK BUSINESS

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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.