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 August , 2011          

To Whom It May Concern

 

In this letter we briefly present the Quality Management System implemented at MTZ Clinical Research, which meets all current GCP requirements and European Standard EN ISO 9001:2008 requirements.

 

The company’s Quality Management System guarantees that the clinical projects are conducted:

  1. Strictly according to the approved study Protocol,
  2. In compliance with ICH-GCP guidelines,
  3. According to applicable international and local regulatory requirements,
  4.  In compliance with European Standard EN ISO 9001:2008 requirements,
  5. MTZ Clinical Research own or Sponsor provided SOPs.

 In August 2009, our company obtained a Certificate of Approval for Quality Management System according
to EN ISO 9001:2008 valid until August 2012. The Certificate is valid for the following scope of operations: “Conduct of contracted clinical trials and operation of MTZ Clinical Research Site.”

 

Maintenance of the system obliges our company to perform control audits carried out by accredited certification organisation. A recent audit, which took place in June 2011, has confirmed proper functioning of the certified system.

 

Required QUALITY which we declare to our Sponsors is achieved by employing specifically educated staff and a constant updating of their knowledge and skills through regular training:

 

  1. in the area of regulations concerning the performance of clinical studies,
  2. in the area of Standard Operation Procedures (SOP) and related documents.

Employees’ membership in the Polish Association for Good Clinical Practice guarantees a constant access to current legal regulations and training programmes concerning the performance of clinical studies.

The Quality Management System ensures the high standard of study documentation and study conduct.
The Quality Management Department is responsible for creating, reviewing and updating, archiving and providing access of:

  1. Standard Operating Procedures,
  2. Process Documents,
  3. General Instructions,
  4. Study Specific Instructions. 

All studies conducted at MTZ Clinical Research are audited at least once during the study course. QC/QA procedures are implemented during the whole course of the trial, from the trial initiation to its completion.

 All actions are undertaken to ensure that the data generated, documented and reported are reliable and presented in   a  required format.

 Our Quality Management Department is fully independent from the study conducting team and reports directly to  the Company’s President.

 Our facility has been audited by many European and North American pharmaceutical companies and received positive opinions.

 We are hoping that this letter answers most questions you may have regarding our Quality Management System.

 

Yours truly,

 

Małgorzata Drop

Quality Manager

MTZ Clinical Research Sp. z o.o.   

  

ISO

EN ISO 9001-2008 Certificate (PDF, 216 kb)

 

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