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Trial Expertise

CRS is offering all clinical trials typically related to Phase I in a broader sense, from First in Human to Proof of Concept. Per year, CRS is handling round about 100 trials, 85% of these trials are Phase I and ca. 90% of these trials comprise modular services, such as CDM and Medical Writing.  A list of our standard trial experience is stated below together with some explaining comments:

First-in-human (FIH)

Approximately 5–7 trials every year are FIH trials. Given its facilities for online PK evaluation, CRS is able to provide PK data for dose escalation meetings one week after last subject dosed in a particular dose group.

Safety and tolerability

Suitable study measures and profiles are tailored depending on specific study requirements and based on the availability of pre-clinical and clinical data on the molecule.

Cardiac safety trials in healthy subjects and patients

About 3–5 trials annually are cardiac safety trials. In some cases CRS cooperates with a central ECG provider, CRS’s preferred partner being eResearch Technology (eRT).

Infusion/injection studies (i.v., s.c., i.c., i.m.)

CRS has a broad range of expertise and state-of-the-art equipment (e.g. Orchestra by Fresenius) for computer-controlled bolus injection, continuous injection, and infusion procedures implemented as standard routines.

Inhalation studies (COPD/asthma)

CRS has extensive experience in conducting trials in respiratory research. Our units in Mönchengladbach and Mannheim have carried out up to 61 studies with respiratory drugs in the past eight years, in healthy volunteers as well as in patients with COPD/asthma (ca. 1700 subjects). In this field, CRS has successfully accomplished trials with NCE, NBE as well as generics to realise first in man, PK, PD and PoC trials. The CPUs are equipped with digital spirometry, body plethysmography, DLCO measurement and ergospirometry. Our staff with a broad clinical experience has been involved in several phase I-IV respiratory studies.

Pharmacology trials (PK, PD, dose-range finding, BA & BE)

CRS has 34 years’ experience in conducting bioavailability trials. It has accomplished hundreds of pharmacology trials. CRS’s clinical teams are able to handle large-scale trials with high sample sizes of N = 200 or more and its resources guarantee the quickest possible performance. CRS has conducted trials in all compound classes including hormones and biosimilars and all modes of administration such as oral, transdermal, buccal and sublingual. In 2008, 2009, 2010 and 2011, the FDA performed inspections of bioequivalence studies and awarded the highest rating in all cases: ‘No Action Indicated’.

Food-drug interaction

Although in most trials a standard high-fat American breakfast has been the interacting principle, low-fat diets, alcohol, sodium chloride and reduced alimentation have also been tested by CRS. CRS works together with an analytical lab in the Netherlands specialising in detailed analyses of meals.

Drug-drug interaction

CRS has performed more than 40 DDI trials, including cocktail approaches on the basis of the Cooperstown Cocktail. More than 22 trials have been published since 1981.

Drug-genotype interaction

CRS conducts various trials in this field to support the increase of beneficial effects and to enhance the prevention of negative effects from drug therapy. Because genetic factors affect human responses to therapeutic drugs, CRS has access to a broad range of genotyped subjects.

Thorough QTc/cardiac safety

CRS has conducted 19 trials with cardiac safety monitoring and central ECG evaluation. Twelve of these studies have been TQT trials pursuant to ICH E14. CRS has cooperated with all relevant core labs (eRT, Ganimed, Nabios, MDS, CardiaBase, Biomedical System) and implemented most of the state-of-the-art technologies. CRS’s expertise covers all kinds of recording equipment (stationary/Holter), trial designs (ambulatory, hospitalized, mixed) and various blinding and dummy procedures. TQT studies are handled in specially arranged clinic surroundings separated from the main clinical activities. This ensures controlled trials without external physical or mental disturbance that might cause inconsistencies in ECG data. Large numbers of subjects can participate in the study.

Narcotics/opioids

Since 2000, more than 20 trials with narcotics have been conducted. During this time, more than 490 subjects have been enrolled. Furthermore, CRS has experience with multiple dose trials, naltrexone blockades, and PD measurement via computerised pupillometry.

Skin safety & dermal treatment expertise

Local and systemic treatment with ointments, gels, film-forming solutions, shampoos, TTS/TDS and occlusive dressings/Finn®Chambers is part of CRS’s expertise. CRS has extensive knowledge in the field of skin-related investigative and safety measurements, the development of TTS/TDS, bioavailability and bioequivalence, topical bioavailability; skin-blanching assay, skin properties (pH, fat and water content), skin irritation and skin sensitisation, and photosensistion and phototoxicity. Since 2007, CRS has conducted 23 dermal-related clinical trials with more than 800 enrolled subjects in Phase I.

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