Medical statistics and translation services
Standard operating procedures;
Advisory and expert services for GxP (GMP, GLP, GCP, GDP, GSP, GPP, GDocP and so on.).
All documents we prepare are written by our experts on the medical scientific evaluation. These documents fully comply with the ICH GCP standard and with the requirements of FDA, EMEA, the Russian Ministry of Health and Social Development, and the Scientific Center for Expert Evaluation of Medicinal Products at the Russian Ministry of Health and Social Development. Scientific documents we prepare can be used both for the studies conducted by us, and for the projects run on your own.
Our specialists design and prepare the following:
Informed patient's consent;
review all submitted documents, and translate them, if necessary;
Our company provides services on the statistical analysis of the results of a clinical study. These services include:
Development and preparation of the documentation of system of quality companies
Certification advisory expertise
Preparing mockups of the primary and secondary packaging
Our specialists are highly qualified for modern multifunctional graphical editors and enjoy a great experience to do the complete workflow on the drug packaging mockup from its design to the final publish-ready file.
Drug efficacy and safety summary;
General investigator's report.
In case of any necessity, our specialists can:
compile, review, and prepare such basic documents as the normative documents and the medical instructions for use;
provide with a list of documents required in the master file;
consulting on, designing and performing the statistical analysis of the clinical study;
and preparing the statistical, medical and summary report on the study.
Registration advisory - expert services
Consulting on the drug master file
prepare the assembled master file ready for submission to the Ministry of Health and Social Development of the Russian Federation.
When registering a medicinal product or arranging a clinical study, there is often a need to process medical and pharmaceutical documents in various languages, especially when the manufacturer of the drug or one of its active ingredients is a foreign company. For this purpose, we hire professional translators.