Due to solid experience of working with the clinical research we managed to accumulate many contacts with the specialists in various fields, which makes it possible for us to provide complete complex of scientific medical support of the Clinical research and the Bioequivalence research and guarantee high quality of the prepared material to our clients:
- Development of the investigator’s brochure
- Development of the research protocol
- Development of Information for the patient
- Development of the Patient’s informed consent
- Development of the Standard surgery procedures
- Development of Resume on the drug efficiency and safety
- Development of the General research report
All the documents are developed by the specialists in the sphere of medical scientific investigation. The documents prepared by us comply with ICH GCP, standards presented in FDA, EMEA, the Ministry of Healthcare and Social Development of the Russian Federation and Federal State Budgetary Institution “Scientific Centre of Medical Products Investigation of the Ministry of Healthcare and Social Development”. The scientific documents can be prepared either for investigations held by our company or for independent projects.
Our company can prepare documentation connected with the clinical research as well as make analysis of the available documents, for example, your reports on preclinical research, literary sources concerning the sphere where your drug is operated and present you a consolidated report on further actions, saying for example if you need to pursue the clinical research, to what extent and with what features should it be pursued.
- Pharmacoeconomic studies
- Development of medical documentation
- Medical statistics and translations