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Recently more and more Russian pharmaceutical companies are beginning to use specialised Clinical Trial Management Systems (CTMS). In Europe and USA use of CTMS has long become an expected ingredient of high quality clinical trial management. In Russia such systems have not yet gained widespread use. One of the first Russian pharmaceutical companies to introduce a CTMS system was Pharmasyntez, who has been working with a Russian clinical software company Flex Databases for almost a year.

“One year ago, when we started working with Flex Databases, we had high expectations of benefits from implementing a software platform, and the result did not disappoint”, says Natalia Malykh, Quality Director at Pharmasyntez. “The Flex Databases system caught our attention by its ability to structure the complete process of clinical and regulatory work. We managed to minimize the effect of personnel changes on project continuity by introducing centralised storage of structured project data. Information from completely different functional areas is stored in a single database. Managers no longer need to jump from one system to another in order to obtain data for decision making. The Flex Databases software platform gives us a solid foundation for growth when the number and diversity of projects are constantly increasing”.

Pharmasyntez has a strong clinical development group, which is split between Moscow and Irkutsk. This comes as no surprise, as the company runs clinical studies nationwide. Data flow in daily from a number of Russian cities, and it is very hard to keep track and process this data using MS Excel.

The need to introduce a CTMS system was clear to the company management, but in order to minimise implementation pain it was important to choose not only a high quality system compliant with the latest international standards, but also a system which is easy to understand and user friendly. CTMS from Flex Databases met these requirements. An additional bonus was that Flex Databases is one of the few companies offering a clinical software platform available both in English and Russian.

As the first step Flex Databases specialists set up a centralised data repository, accessible from anywhere in the world 24/7. Multiple category references used by Pharmasyntez were uploaded into the system.

Information is uploaded in a highly structured format, which hugely reduces data entry errors. Standard data and auto-prompts are stored in the system. For example, the system prompts the user to select the correct city name Saint Petersburg instead of St. Petersburg or SPB, preventing a data entry error. As a result data conforms to a single standard, despite being entered by different people separated by thousands of miles. This improves data quality and analysis. A report showing the true status of a large multicentre trial spread across dozens of cities can be generated with only a few mouse clicks, allowing to quickly make the right management decision.

Flex Databases customised CTMS solution for Pharmasyntez. In addition to HR-catalogue and centralised data repository, a finance control system was added to standard tools of clinical trial management. The new program stores and tracks the status of all investigator/site contracts and invoices. These data, when pulled together, allows to generate a report on a study budget with a few clicks, clearly showing how much money had been spent, which invoices are being processed and what expenses are forthcoming. This feature is very important for pharma companies, as accumulation of finance data across projects allows to forecast future study costs with variance no higher than 5%.

“We are delighted with our partnership with Pharmasyntez”, says Timur Galimov, Technical Director at Flex Databases. “Data reconciliation and movement is one of the biggest challenges faced by pharmaceutical companies. Once a company reaches a certain size, the time and costs required for data reconciliation from different sources start increasing rapidly. By using our software platform Pharmasyntez solved a number of growth related problems.”

Use of the modern IT technologies in clinical trial management contributes to the quality of medicinal products coming to the Russian market. As the degree of adoption of such technologies by companies increases, so will the quality of the clinical trials.

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