Clinical Trial Design, Clinical Trial Monitoring, Consulting, Data Management, Efficacy Studies, GCP Compliance, GLP Compliance, GMP Compliance, Project Management, Trial Management
CRS is a full service CRO in Phase I-IV. The holding comprises four CPUs: CRS-Kiel with additional clinical unit in Lübeck, CRS-Moenchengladbach and CRS-Mannheim. Each unit has experience in clinical trials in Phase I – II for over three decades. Moreover, the Mannheim/Gruenstadt unit is also engaged in the coordination of Phase III – IV trials and offers Bioanalytics, Medical Writing, Clinical Data Management & Statistics as modular services.
Early Phase I-IIa
Contrary to the general tendency, CRS is steadily expanding. With more than 240 beds in total, CRS is the number one CRO in Europe regarding bed capacities. Besides, the CRS units provide capabilities for ambulatory trial designs. Supplementary to standard human pharmacology work in Phase I, CRS provides clinical trials in renal and hepatic impaired patients, Thorough QTc trials with various central ECG labs and additional assessments of PD parameters in CNS, gastrointestinal research and pneumology, i.e.
• First in man
• Proof of concept
• Safety and tolerability
• Dose finding
• Bioavailability and bioequivalence
• Microdialysis (tissue distribution)
• Food-Drug interaction, Drug-Drug interaction
• Pharmacokinetic / pharmacodynamic trials
• Skin safety / pain models
• Telemetry ECG recording
• Thorough QTc trials according to the guidelines
Clinical Development Phase IIb-IV
The department Clinical Development of CRS also offers conduction and project management of your clinical studies in Phase IIb-IV with a full range of services, including strategic planning, clinical development, consultancy and regulatory expertise to move a product forward in development, i.e.
• Phase 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 consulting
• KOL/advisory board identification & management
• IND/IDE consultation
of CRS is GLP certified since 1992 and FDA inspected (2002, 2008 and 2011). Within more than 30 years, more than 300 analytical methods have been developed and validated. The analytical equipment complies with international standards.
of CRS is equipped to handle IMPs and is staffed with high qualified persons according to §14 AMG (German Drug Law). It is GMP certified and possesses the manufacturing licence.
Clinical Data Management
of CRS 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.
of CRS takes over 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.
of CRS is centrally organised for the whole CRS Group. The department is responsible for performing audits during clinical and bioanalytical studies according to GCP, GLP, GMP and the respective legal requirements.