Regulatory support
Globe Medical provides services for obtaining all possible documents, which are necessary for conducting of Clinical Trials.
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Clinical Trials
Labeling and Re-Labeling
In accordance with Russian legislation, the investigational drug should be labeled accordingly. Labels should contain full information which is indicated in the order #61 of the Ministry of Health. The label on the package must be in Russian and be used while during the Clinical Trial.
Purchasing of comparators and concomitant medications
Organization of procurement of comparators and concomitant drugs are required for most of Clical Trials. Globe Medical has reliable partners on the local and foreign markets, cooperates with wholesalers and offer the supply of medicines and medical products directly for the Clinical Trials.
Recall & Reject & Destruction
Globe Medical organize Recall and Return procedures in accordance with Russian legislation and GxP requirements. After receipt of the materials, they should be verified by quantitative and qualitative characteristics and placed in a special quarantine storage area.
Supply of reagents and reference standards
Importation of medicines in the Russian Federation has always been a time-consuming process. Competition at the Russian market of medicines requires an operative solution of all logistics tasks. Delays with delivery of samples for clinical trials / preclinical researches may delay the start of sales.