In 2006 CRS was merged on the basis of three former independent phase I CROs in Germany with more than 20 or rather 35 years of experience in clinical pharmacology. Today, more than 300 beds are distributed over six CPUs in Germany (Kiel, Lübeck, Berlin, Wuppertal, Mönchengladbach & Mannheim), and hence CRS is the leading European CRO in the field of early clinical trials. It was successfully audited by national authorities and the FDA.
CRS offers full-service in phases I to IV to pharma, biotech and drug delivery industries worldwide either in a hospitalisation or an ambulatory setting. The company conducts the complete range of high-quality clinical trials from FIM to POC trials plus trial specialities like TQT, skin safety, respiratory research, renal/hepatic insufficiency and women’s & men’s health with geographic focus on Europe & Israel.
Besides the six CPUs a centralised department for Clinical Development and for modular services such as Monitoring, Consultancy, Medical Writing, Clinical Data Management, Biometrics and Bioanalytics belong to CRS. Labelling, packaging and preparation of trial medication can be offered as well due to CRS’ GMP certification.
Early Clinical Development Phases I-IIa Department
Contrary to the general tendency in this field, CRS is steadily expanding e.g. through the latest acquisition in July 2013 when CRS took over the phase I CPUs from Bayer HealthCare in Berlin and Wuppertal. Furthermore, CRS opened its first CPU in a University Hospital setting and gains access to patients as well as to diagnostic/therapeutic expertise and equipment. A substantial part of the business is the conduct of patient trials in phase IIa, such as POC trials as well as studies in therapeutic equivalence and bioavailability in patients.
Exemplary working experience:
· Safety and tolerability
· Cardiac safety trials in healthy subjects and patients
· Infusion/injection studies (i.v., s.c., i.c., i.m.)
· Inhalation studies (COPD/asthma)
· Pharmacology trials (PK, PD, dose-range finding, BA & BE)
· Food-Drug interaction
· Drug-Drug interaction
· Drug-genotype interaction
· Thorough QTc/cardiac safety
· Skin safety & dermal treatment expertise
Late Clinical Development Phases IIb-IV Department
has 20 years of proven experience in providing clinical research services and has conducted numerous clinical trials in various therapeutic areas. Its experience in running complex clinical trials puts CRS head and shoulders above its competitors in terms of quality and flexibility. It offers the full range of services commonly required to conduct clinical trials, including non-interventional studies and registries, i.e.
· Phases IIb-IV clinical trial management
· Project management
· Site selection & qualification, training and support
· Clinical and medical monitoring
· Electronic data capture and management
· Patient registries
· Strategic consultancy
· KOL/advisory board identification & management
· IND/IDE consultation
CRS was the first CRO in Germany to be awarded a GLP certificate in 1992 and it has always been renewed ever since. Its bioanalytical unit has been successfully inspected on several occasions by various national authorities (BfArM, FDA and AFSAAPS). CRS has augmented its clinical services with bioanalytical method development, method validation and sample analysis of small molecules. More than 300 validated assays are available.
All CRS units are able to satisfactorily handle trial medication, either investigational medicinal products (IMPs) or marketed reference products, pursuant to Section 13 AMG. As a unique feature, our facility in Mönchengladbach has been licensed since 2004 and is in possession of an almost unrestricted manufacturing license in accordance with GMP rules.
Clinical Data Management & Biometrics Department
provides all the services necessary to handle the data of clinical studies and treatment observation in full compliance with CFR 21, part 11 (as confirmed by internal GAMP4 validation). It offers services in study planning such as statistical trial planning, CRF design, randomisation and design of data structures. Throughout study conduction our team can offer database set-up, data entry with Oracle Clinical, data transfer to third parties, data validation including programming as well as query management, medical coding and biometrical/PK evaluation.
Medical Writing Department
prepares study protocols and integrated reports according to ICH as well as IBs, PSURs, publications, lectures, posters, pharmacological/toxicological reports and clinical expert reports. All systems of Clinical Data Management are validated according to 21 CFR part 11.
Quality Assurance Department
The independent Quality Assurance Department is responsible throughout the CRS-Group. It is responsible for performing audits during clinical and bioanalytical studies according to GCP, GLP, GMP and the respective legal requirements.