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Data Matrix miniEDC

Product
Developers: Data Matrix
Date of the premiere of the system: Announcement: 2018/06/18
Last Release Date: 2019/04/24
Branches: Pharmaceutics, medicine, health care
Technology: MDM - Master Data Management - Management of the main master data,  SaaS is the Software as service

miniEDC is the professional Russian-speaking cloud platform for collecting and data processing developed for the pharmaceutical industry.

2019: miniEDC output to the South Korean market

On April 24 the St. Petersburg company Data Matrix announced agreement signature about cooperation with Seoul CRO, one of the leading contract research organizations of South Korea. This document gave start to implementation of IT developments for the Korean pharmaceutical industry.

Within the agreement the Russian developer of providing and provider of services in data processing and automation of clinical trials Data MATRIX assigns exclusive rights on application of the solutions Seoul CRO, in parallel with it, the companies will be engaged in implementation of IT products and cloud services in the local market.

The situation in the Korean market in KI is similar to a situation on Russian where many projects are kept on paper individual registration cards of patients. Implementation of electronic solutions, automation and online monitoring of data gives the essential advantages obvious in terms of investments and terms.

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We see huge interest in our products from partners in Korea. It is dynamically emerging market where there are a lot of ambitious companies aimed at geographical expansion. Our developments help to increase their competitiveness and, eventually, promote success of their business strategy.
Ekaterina Churzina, head of development of Data MATRIX
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Results of the cases which are already implemented by Data MATRIX for partners in Russia, Europe and the USA show reduction of time expenditure on a set up and project closure of clinical trial to 40%, decrease in the total costs to 70%. Besides, the algorithms registered in a system exclude incorrect data entry, data loss, allow to monitor the research course online that increases quality of data and the most clinical trial.

In addition to economic incentives of implementation of IT products to it there are also regulatory premises: in the nearest future the industry expects toughening of requirements from the Korean regulator, including introduction of regulation on compulsory use of electronic platforms for collecting and data processing.

Modern technologies not only help the companies to optimize expenses within clinical trial - one of the most expensive stages of development of medicine, but also to create data according to the international standards that considerably increases the export potential and opens a possibility of an exit to the global pharmaceutical market before the local companies.

2018: Announcement

The Data Matrix company submitted on June 18, 2018 the software product created based on cloud computing for data collection in clinical trials in Russia. The product received the name miniEDC and, according to developers, will become a worthy alternative to foreign platforms, simplifying work of pharmaceutical companies and contract research organizations.

According to Ivan Dobromyslov, the chief executive of Data Matrix, the growing requirements of regulators to quality of these clinical trials and also aspiration of organizers of clinical trials to independent work with data in a modern digital format became drivers to creation of a product.

The functionality of solution SaaS answers international (ICH GCP, CRF 21, part 11) and to the Russian (Order No. 200n, 152-FZ) standards of submission of data in regulatory bodies. The platform passed internal test and received the status of the validirovanny software which is confirmed by a packet of validation documentation, told in Data Matrix.

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The last 10 years are mentioned by significant growth in technology achievements in the field of health care and pharmaceutics, but only pass 50% of clinical trials in Russia using electronic data collection. The others — on paper carriers and in spreadsheets of Excel. In Russia the era of digital health care began, and the local market is not ready to it. miniEDC will correct it. We consider that we made the contribution to the import substitution program — the head of department of data processing of Data Matrix commented on value of development of Ania Markosyan.
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miniEDC also the form designer, an opportunity to check and do unloading of the built-in and configured forms given using has the built-in library. It is enough to users of the platform to have basic skills of work with office applications independently to conduct a research in the reduced terms, having obtained at the same time qualitative data.

According to Data Matrix, interest in miniEDC was already shown by a number of the pharmaceutical companies. The company shows the interface and functionality of the application so far. Accesses to the demoversion are issued at the request of official representatives of pharmaceutical companies and the contract research organizations.