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Bioanalytics
Since its foundation in 1977, the department Bioanalytics of CRS has specialised in chromatographic analysis of drugs and their metabolites in biological samples.
Working in close contact with our Sponsors and clients for more than two decades, we have developed and validated more than 300 analytical methods.
Our analytical equipment complies with international standards:
The laboratory is equipped with state-of-the-art chromatographic equipment like:
- LC/MS/MS (1 SCIEX API5000, 1 SCIEX 4000, 2 Micromass Quattro Ultima, 1 Micromass Micro),
- LC/MS (Agilent 1100),
- GC/MS, HPLC/UV, -fluorescence, -electrochemical detectors and GC/ECD, GC/NPD and GC/FID.
Additionally ELISA reader and washer (Bio-Tek) are implemented in our laboratory
As the first national CRO we obtained a GLP certificate in 1992 which was renewed in 1996, 2000, 2004 and 2008. Three FDA inspections (1991, 2002 and 2008) have been passed successfully
Clinical Data Management
The Data Management team of CRS has experience in handling and evaluating data of clinical trials for more than 20 years.
Data Management covers all the services necessary to handle the data of clinical studies and treatment observations ("Anwendungsbeobachtungen") according to current regulations. Mathematicians and statisticians, supported by IT-specialists and Clinical Data Managers, effectively manage the evaluation of clinical studies, from in-house Phase I - to multinational Phase III and IV studies.
Our software is validated and nearly every industry standard is available.
Services:
- Trial Planning
- Trial Conduction
- Trial Evaluation
- Software for Data Management and Biostatistics
Medical Writing
Our Medical Writing team is responsible for preparing Study Protocols and integrated Study Reports according to ICH or Sponsor SOP as well as Investigator Brochures, Periodic Safety Update Reports (PSUR), publications, lectures, posters, pharmacological/toxicological reports and Clinical Expert Reports according to Notice to Applicants, translations German/English – English/German.