Flex Databases

Flex Databases is the company providing complete software solutions for process automation of development and testing of medicines.

The programs developed by Flex Databases allow to implement quickly new functionality, to set up individual solutions for each client and to quickly connect different modules of the platform. The modules provided by Flex Databases company: CTMS (Clinical Trial Management System), EDC (Electronic Data Capture), Budget & Project Management), eTMF (Trial Master File), CRM (Customer Relationship Management), Finance, LMS (Learning Management System), BPMS (Business Process Management System), HR (Human Resource), Time sheets and others.

The state accreditation in information technology field is issued by the Ministry of Telecom and Mass Communications of the Russian Federation, register No. 2939.

Use of the special software allows to save up to 1 million dollars monthly on carrying out clinical trials

Analysts of Flex Databases company came to such conclusions. Based on internal assessment they found out that use of the special software for performing clinical trials saves in total to all clients of the company up to 1 million dollars a month. It is reached thanks to complex automation of process of clinical trials.

Considerable part of expenses when performing clinical trials are the share of activity of monitors. They provide correct filling with doctors of the individual registration cards (IRC) of patients. Depends on quality of their work whether results of clinical trial will be recognized by the regulatory bodies which are responsible for state registration of medicines. The pharmaceutical companies pay to monitors regular business trips in the research centers, permanent long-distance negotiations on phone.

"At implementation of electronic IRK (e-IRK) within the Electronic Data Capture (EDC) software application expenses on activity of monitors are considerably reduced. Economy only on logistics reaches 70%. Monitors online keep track of quality of filling with doctors of e-IRK and give operational consultations. There is no need to make long business trips in the research centers scattered through the whole country it is possible to control everything on a centralized basis", – the director for marketing and business development of Flex Databases company Loginovskaya Olga tells.

Introduction of e-IRK minimizes influence of a human factor and a possibility of an error. The program will not allow to enter incorrect value and will provide information on all fields where there were introduced errors or data were entered repeatedly. An EDC system considerably simplifies process of tracking and check of correctness of data in IRK for the monitor and the manager on data processing (Data Manager) and also allows the medical monitor to monitor safety of patients more effectively.

Powerful benefit of use of EDC systems is full automatic control and fixing of all transactions made by users in a system. Data loss becomes impossible. The Flex Databases company, in addition to parallel data storage (clustering) in several data centers, performs 6 backup copies every day on servers in Russia and if it is necessary, in Europe. Therefore it is always easy to trace any error and to quickly make corrections without tightening of terms of carrying out clinical trials.

"Minimization of inaccuracies when filling IRK – an important figure of merit of performing clinical trials. The hard error in IRK can delay state registration of medicine for an indefinite term. For the pharmaceutical company it is fraught with the considerable financial losses sometimes reaching millions of dollars. Therefore we implement to our clients a single software platform for performing clinical trials. It allows to control online quality of carrying out clinical trials at all stages and to accurately plan terms. Here not only EDC, but also the modules allowing to manage resources of the company, to conduct financial management, to systematize and accumulate information enters, is structured to store files, to manage the corporate knowledge base and others. All these modules are a single multifunction platform", – Galimov Timur, the technical director of the company of Flex Databases notes.

Implementation of separate modules cuts down expenses of clients of Flex Databases company to 85%. For example, system implementation of e-learning (LMS) cuts down expenses on management of trainings in the organization almost for 80%, and the system of management of resources leads up to 25% to economy. Usually all these programs are bought by the organizations conducting clinical trials (the pharmaceutical companies and the contract research organizations) separately that turns out very expensively. Systems using the different technologies provided by different providers often clash with each other. The single platform allows to avoid these problems.

Use of a number of the programs which are specially configured under the purposes of clinical trial considerably increases at once its quality and significantly saves financial resources.