Clinical Laboratory as "Central Lab"

For our Clinical Pharmacology Unit or Patient Trials, full management of Clinical Safety, including:

  • Project management and communication with the sites

  • Preparation of a detailed laboratory manual

  • Lab Kits organization

  • Receipt of samples 24/7

  • Analysis 7 days a week

  • Reporting

  • Support site personnel (troubleshooting)

 

Quality

  • According to Reflection Paper
    (EMA/INS/GCP/532137/2010, 28 February 2012)

  • RiliBÄK (Guidelines of the German Federal Medical Council):

    • Proficiency Testing (INSTAND e.V.; RfB)

    • Internal Quality Samples (at least two levels/working day)

  • OP-Q for new equipment

  • Verification of Method Performance (precision & accuracy; reference range)

  • Method Validation (on request)

 

Available Instruments

Clinical Chemistry

Integra 400

Analyzer

cobas 6000 / c 501- e 601

Immunoanalyzer  

(Serology; HIV 1/2, Hormones)

cobas e 411

 

Hematology Analyzer

Sysmex XT-2000i

Coagulation

cobas t 411

Urine Analyzer 

cobas u 411

 

Contact

Business Development
Please send us an Email!

 

 

Dr. Sylvie Bruchmann
Vice President

Dr. Jutta Michael-Hepp
Scientific Expert GCLPD

James Dickinson
Global Head 
of Clinical Services

Dr. Florian Schwaak
Director 
Business Development