CENTRAL LABORATORY
 
Laboratory compliance with medical and scientific goals of the study is continuously ensured by PHAMOS' project management, supervising performance and results.



Experience and Quality

PHAMOS' partner "Lékařské laboratoře s.r.o." Prague has earned valuable experience having provided full laboratory backup to numerous clinical trials throughout Europe. By implementation of an environmental management ac. to ISO 14001 Lek Lab  is minimizing the ecological impact of its business on the  environment. By means of ISO 15189 LekLab assures that services are provided with highest quality and at a high technical and professional level.

 
ISO- certification ac. to

9001/ 2000 

14001/ 2004 - environmental management

15189/ 2007 - quality management

continuous supervision by quality assurance systems of the National Institute of Public Health and the National Reference Laboratories

certification of selected domains by DGKC (German Ass. for Clin. Chemistry) SEKK


Lab Services and Equipment

 
Biochemistry, Haematology, Bacteriology, Serology, Parasitology, Mycology, Pathology, Immunology and others

Upon request, specific procedures of the protocol could be installed, as e.g. blinded (double) assessment, preparations for further evaluation in other institutes etc.

High-tec devices of world's leading manufacturers in use with a daily capacity of about 1.000 samples for blood/serum and about 300 for bacteriological testing. Continuous servicing provided by manufacturer- acknowledged organisations.


Logistic Services


 
Provision of sampling sets acc. to protocol

Provision of lab manual, various languages available, supervised by PHAMOS' medical project manager

Provision of shipping documents, customs declaration and package kits in compliance with IATA 650

Established co-operation with the local branch of an international courier service direct supplies to trial sites, re-supply on demand, sample pick-up, sample tracking, customs clearance, cold supply chain and storage, accountancy for courier costs and customs fees


Staff


 
highly qualified personnel (currently about 100 employees)

11 MDs and 5 employees with non- medical university degrees

58 laboratory technicians, 21 of which with board exam

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