Services Clinical research

Studies of phases I, II, III, IV

• Planning of research objectives; 

• Experimental plan design and preparation of the corresponding 

• Case Report Form (CRF); 

• Selection of the centres (which can be identified autonomously or indicated by the customer); 

• Contacts with investigators; 

• Formal and administrative tasks; 

• Study coordination and supervision; 

• Monitoring; Quality Assurance; 

• Data collection and evaluation; 

• Data entry, and statistical analysis; 

• Writing up of the final report;

All studies are carried out following internal SOP’s or those of the customer in conformity with the Good Clinical Practises adopted by the EMEA during the plenary meeting of the CPMP of the 17th July 1996;Good Clinical Practice: Consolidated Guideline (CPMP/ICH/135/1995) taken into account by the Italian Ministry of Health with the Ministerial Decree of the 15th July 1997, published in the “Parte Prima of the Gazzetta Ufficiale n. 162 of the 18th August 1997 (Ordinary Supplement of the Gazzetta Ufficiale n. 191 of the 18 th August 1997). 

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