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Search for "inspection"

Displaying results 1 to 5 out of 5

  Mailing Campaign (Kopie Home) 81%
  ... extended sample processing Large clinical capacities - 6 clinical units with over 275 beds in Germany High quality - multiple authority inspections (FDA, EMA, BfArM, AFSSAPS, ANVISA, DHMA, etc.) Broad panel of subjects - access to patients, special populations and healthy ...
  Size: 33 K - Created: 11-01-17 - Modified: 20-12-17 11:58
Path: /Home/Mailing Campaign (Kopie Home)

  Kiel 79%
  ... and cooperates with LKF (Laboratorium für Klinische Forschung GmbH). CRS-Kiel operates to GLP standards and has successfully passed several GCP inspections. Dr. Torben Thomsen , Ekkehard Herrmann and Dr. Atef Halabi are the managing directors of CRS-Kiel. History In 1992, the unit in Kiel was ... special patient population studies (e.g. renal/hepatic impairment trials). In 2000, the unit joined the IKP Group and successfully passed FDA
  Size: 33 K - Created: 18-11-12 - Modified: 20-12-17 11:58
Path: /Locations/Kiel

  QA & QC 75%
  ... Conducting system audits in-house and at external clinical sites; vendor qualification function of other external providers  Preparing inspections by sponsors and regulatory authorities; representing CRS vis-à-vis external organisations including the FDA, sponsors and other organisations; ...
  Size: 31 K - Created: 18-11-12 - Modified: 20-12-17 11:58
Path: /Services/QA & QC

  Data Protection 71%
  ... departments, as well as the persons responsible for clinical trials. It may also be viewed by commissioned third parties in the event of inspections by the authorities or sponsor audits. Information in the electronic customer data management file and on supplier qualification will be stored ...
  Size: 33 K - Created: 27-06-17 - Modified: 20-12-17 11:58
Path: /Contact/Data Protection

  Trial Expertise 66%
  ... and all modes of administration such as oral, transdermal, buccal and sublingual. In 2008, 2009, 2010, 2011 and 2014, the FDA performed inspections of bioequivalence studies and awarded the highest rating in all cases: ‘No Action Indicated’. Food-drug interaction Although in most trials a ...
  Size: 35 K - Created: 18-11-12 - Modified: 20-12-17 11:58
Path: /Expertise/Trial Expertise

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