ARS PharmRussia + Clinical Trial Management System (CTMS)

In May, 2014 the Clinical Trial Management System (CTMS) system of the Russian company "Flex Databases" was purchased by the domestic contract research organization of "ARS PharmRussia". The CTMS system solves one of key tasks – exact compliance of the project to the set terms. By estimates of specialists the medicine entry delay into the market only for one day is wrapped for the pharmaceutical company in losses about 1 million dollars. The CTMS system minimizes risk of similar incidents. The program allows to control the course of clinical trial online 7 days a week 24 hours a day from any place in the world. It is possible to trace real costs of time for the project, progress of accomplishment of tasks, an adherence to deadlines on the project in general and on specific objectives.

Many Russian CRO, however, still continue to use Excel as the main tool on management of KI. The budget is planned on the basis of "sixth sense" and experience of the specific specialist or group of specialists, but not on objective data. Earlier such practice was characteristic also of the western countries. According to data of the Tafts Center for studying and development of drugs (Tufts Center for the Study of Drug Development) in 2010 the western specialists considered acceptable a 20% rejection of the actual budget KI from planned. Provided that today expenses on one clinical trial can reach hundreds of millions of dollars and sometimes even several billion, such serious error in 20% – very strong blow to the budget. The modern CTMS systems can provide 95%, and often and more full compliance of the planned budget to actual expenses. Economy – hundreds of thousands of US dollars.

"System implementation of CTMS – a natural step to implementations of our strategy for increase in effective management of clinical trials, – Anna Shevchenko, the director of management of clinical trials of ARS PharmRussia company tells. – It is very important to lay a strong basis for growth in time. The number and variety of projects which we conduct now constantly increases. Therefore there has to be a complete confidence that implementation of each of them conforms to the high quality standards. We saved up big knowledge base on the CTMS systems existing in the market therefore a choice was made very quickly. The software platform of CRO Starter Kit™ of Flex Databases company includes all necessary tools for work of regional CRO. First of all, it is a system on budget management and process of clinical trial – Budget & Project Management System and also the system of e-learning of personnel – Learning Management System (LMS). These are convenient tools for control and measurement of the key processes accompanying conducting clinical trial and of course, training of employees at the highest level".