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Early Phase I to IIa

Each clinical trial brings new challenges and has to be seen from an individual perspective. The staff of CRS’s clinical pharmacological units (CPUs) dedicated itself to respond to these challenges for nearly 40 years. All of CRS’s Phase I–II units are experienced in conducting all types of clinical pharmacological trials. These units are independent companies which are controlled by the parent company CRS Clinical Research Services Andernach GmbH. Their total bed capacity exceeds 275.

Further information

Besides the standard performance of human pharmacology trials, each of the units has developed its own special expertise based on different clients’ needs and requirements.

The division of the corporate structure into six professional Phase I units staffed by well-trained personnel has several advantages:

  • Variable trial designs
  • The possibility of splitting large trials (mono- or multi-centric)
  • Decentralised subject recruitment
  • Central modular services for all locations

In order to maximise quality, each unit of CRS operates to a centralised common standard operating procedure (SOP) and a total quality management system (TQM). This enables to split up very large trials and allows the decentralised, parallel screening and recruitment of healthy volunteers and patients.


Accommodation

Each clinic provides accommodation of hospital or hotel standard for volunteers and patients. It is combined with spacious lounges (including libraries, televisions and video projectors with a 5.1 sound system), Internet and quality cuisine to make participants feel as comfortable as possible. The arrangement of different wards and lounges in all units allows separation between patients and healthy volunteers as well as between patients of different age groups. Standardised meals are freshly prepared by trained CRS chefs or delivered by external catering services. Special dietary needs (especially in connection with pharmacokinetic profile days, food-drug interaction studies and the long-term nutrition of hospitalised subjects) can be easily met without affecting laboratory parameters.

Volunteer/Patient Panel

CRS constantly recruits new healthy volunteers and patients to ensure wide variety of subjects for its clients. CRS currently has more than 28,000 volunteers on its books. In addition, it has access to volunteers with symptoms, including allergic, hypertensive and hyperlipidemic subjects. Special panels of genotyped subjects such as poor metabolizers (PM) for a certain cytochrome isoenzyme are also available.

CRS has access to various panels of healthy subjects, healthy subpopulations and patients.

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