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Quality Assurance



CRO - Quality Management Standards

Clinical Studies



Klifovet offers audits by independent quality assurance managers for assuring the quality of all stages of a clinical trial including checking compliance with the protocol and the operating procedures used by the study participants.


Under the responsibility of the KLIFOVET management, audits at the following steps could be contracted independently or as integral part of clinical studies contracted to KLIFOVET:

The internal quality assurance department offers:

  • Audit of the study protocol
  • Site Audits during the course of the study
  • Audit of the master study file including a 10% verification of raw data against the data listing
  • Audit of the final study report

Audits are always based on the contractual arrangements.






 



Contact Person


Dr. rer. nat. Claudia Laskowski Send an E-Mail

Dr. rer. nat. Claudia Laskowski

Head of Quality Assurance, Auditor in the clinical development of pharmaceuticals and medicinal products (GQMA)


Biometrie and Data Management



Database Validation is offered by independent quality assurance managers for clinical studies using Studybase® an electronic data capture developed by Klifovet.


GMP complient Product Store



KLIFOVET’s QA Department ensures a GMP-compliant product store, Wholesale and the Authorisation for Marketing of Feeding Stuff.

Klifovet offers manufacturing of clinical supplies (repackaging and labelling) for clinical trials conducted by Klifovet, and can provide a QP for commercial EU batch releases.