About us
Flex Databases is a team of professionals that will help you to run clinical trials most effectively
 
Specialists of Flex Databases have great experience and background in clinical trials which made the resulting product customized to our particular needs.
 
Natalia Nayanova. Director, Clinical Operations, Accell Clinical Research
History
1997

 
2005

 
2011

 
1997

 

Founded in 1997 as a software company providing software solutions for the banking industry, Flex Databases became the first Russian IT company specializing in developing comprehensive software solutions for business process management in the Clinical Trials industry globally. Today we are proud to see among our clients scores of Contract Research Organizations (CROs) and Pharmaceutical Companies operating not only in Western and Eastern Europe but also in Asia and the US as well.

2005

 

In 2005, we developed our first universal business application specifically for the CRO. Using our knowledge and experience gained through our work in the financial sector, we gradually adapted our platform for the specific needs of clinical trials. As we developed our platform, we came to the conclusion that the pharmaceutical industry is lagging behind other industries in adopting a platform approach, and our PSA platform is the perfect match for both CROs and companies working in pharmaceutical development. This led to our shift to working exclusively in healthcare research.

2011

 

In 2011, we re-branded as Flex Databases and began marketing our platform as a solution for CROs and Pharmaceutical companies. Our unique experience and qualified team of 60 professionals with broad experience in clinical trials made it possible to create a flexible platform that combines solutions for general management (HR, time sheets, workflow management, budget & project management, Learning Management System, expense reporting) and solutions specifically developed for business process management in clinical trials (CTMS, EDC, Trial Master File).

Clients
Certification

In 2014 Flex Databases received the Russian Federation accreditation for working in information technology. This accreditation is a confirmation that Flex Databases meets the requirements defined in the regulations “On the state accreditation of the organizations carrying out their activities in the information technologies field”, approved by the resolution of the government of the Russian Federation on November 6th, 2007, #758. The Company was entered into the state registry of information technologies companies.

 

Flex Databases is a member of the Microsfot BizSpark program. This is a program for supporting technology start-ups. As part of this program, Flex Databases gets access to software development tools, platform technologies and server products, support and training from Microsoft.

Federal accreditation recognizes Flex Databases as an established software development company and opens opportunities for participation in the government tenders and industry support programs.

Benefits and Technology
  • Professional team with expansive work
    experience in clinical trials
  • Individual approach to each customer
  • Efficient helpdesk team
  • Compliance with deadlines
Modules
Platform

All of Flex Databases’ applications are created by our team without third-party acquisitions or integrations offered on the market. We rely on Microsoft.NET Technology and SQL Database principles. Due to the flexibility of our applications, they can be easily adapted to the specific needs of each client.

Main features of our platform:

  • Single log-in
  • Single data source, no need to integrate data from different sources
  • Consistent look and feel, with same reporting and export tools throughout the platform
  • Uniform representation of data (grid) with built-in drag and drop ad-hoc reporting
  • Electronic signature
  • Built-in audit trail for all actions
  • Easy configuration for clients’ needs (modification of fields, reports, etc.)
  • Possibility of individual customization for each client
  • Ability to describe and manage business processes using built-in tools with no need for programming
21 CFR Part 11

Flex Databases system satisfies the FDA requirements (Part 11 of Title 21 of Code of Federal Regulations, U.S. Department of Health and Human Services; 21 CRF Part 11), including:

  • Safe electronic records storage, their accurate and ready retrieval throughout the retention period
  • Automatically generated audit trial which records the date and time of each entry and action performed by any system user
  • Use of authority checks to ensure that only authorized individuals can use the system in accordance with their access rights
  • Use of operational system checks to enforce permitted sequencing of steps and events in the system
  • Use of operational procedures to ensure password safety (such as password aging)
  • Use of electronic signatures providing integrity between record and signature related to it

Flex Databases confirm meeting 21 CFR Part 11 technical requirements by employing necessary operational procedures and controls that include validation of GxP functions to ensure accuracy, reliability, consistent intended performance and the ability to recognize invalid or altered records.

Integration

We have considerable experience in integrating our platform with other software applications, including various EDC and IVRS/IWRS packages, Customer Relationship Management applications (CRM), and with various enterprise applications like SAP, 1C, Microsoft Dynamics and Navision.

Each integration scenario is unique and can be handled in different ways. Please contact us with your specific request, and we will be happy to discuss the necessary effort and timelines.

Hosting

One of the most important aspects of our work along with multitasking and flexibility is reliability of data storage and uninterrupted access to our services. We use the latest fail-safe technology in order to ensure accessibility and security of data.

  • Only certified data centers
  • Reliable hardware
  • Virtualization
  • Clusterization
  • Data storage on private cloud for each client
  • Monitoring of the systems 24/7
  • Reliable reserve backup
  • Strict access rules

 

All of Flex Databases’ applications are created by our team without third-party acquisitions or integrations offered on the market. We rely on Microsoft.NET Technology and SQL Database principles. Due to the flexibility of our applications, they can be easily adapted to the specific needs of each client.

Main features of our platform:

  • Single log-in
  • Single data source, no need to integrate data from different sources
  • Consistent look and feel, with same reporting and export tools throughout the platform
  • Uniform representation of data (grid) with built-in drag and drop ad-hoc reporting
  • Electronic signature
  • Built-in audit trail for all actions
  • Easy configuration for clients’ needs (modification of fields, reports, etc.)
  • Possibility of individual customization for each client
  • Ability to describe and manage business processes using built-in tools with no need for programming

Flex Databases system satisfies the FDA requirements (Part 11 of Title 21 of Code of Federal Regulations, U.S. Department of Health and Human Services; 21 CRF Part 11), including:

  • Safe electronic records storage, their accurate and ready retrieval throughout the retention period
  • Automatically generated audit trial which records the date and time of each entry and action performed by any system user
  • Use of authority checks to ensure that only authorized individuals can use the system in accordance with their access rights
  • Use of operational system checks to enforce permitted sequencing of steps and events in the system
  • Use of operational procedures to ensure password safety (such as password aging)
  • Use of electronic signatures providing integrity between record and signature related to it

Flex Databases confirm meeting 21 CFR Part 11 technical requirements by employing necessary operational procedures and controls that include validation of GxP functions to ensure accuracy, reliability, consistent intended performance and the ability to recognize invalid or altered records.

We have considerable experience in integrating our platform with other software applications, including various EDC and IVRS/IWRS packages, Customer Relationship Management applications (CRM), and with various enterprise applications like SAP, 1C, Microsoft Dynamics and Navision.

Each integration scenario is unique and can be handled in different ways. Please contact us with your specific request, and we will be happy to discuss the necessary effort and timelines.

One of the most important aspects of our work along with multitasking and flexibility is reliability of data storage and uninterrupted access to our services. We use the latest fail-safe technology in order to ensure accessibility and security of data.

  • Only certified data centers
  • Reliable hardware
  • Virtualization
  • Clusterization
  • Data storage on private cloud for each client
  • Monitoring of the systems 24/7
  • Reliable reserve backup
  • Strict access rules

 

Team
Evgenia Mikhalchuk
Director Business Development

Evgenia Mikhalchuk is in charge of all Business Development activities at Flex Databases. She brings on board 10 years of industry experience, 8 of them working in BD and QM roles in a global CRO. BD formed Evgenia in an extremely client oriented professional and QM gave Evgenia an in-depth understanding of industry processes as well as of the latest industry standards and trends. This combination together with extensive industry training allow Evgenia to provide knowledgeable advice on how e-Systems can help R&D companies and provide meaningful suggestions on processes management and system implementation. 

Evgenia is always eager to provide a consultation and tell you about our services.

Call Evgenia +1 844 335 1270 or shoot an email to her team at This email address is being protected from spambots. You need JavaScript enabled to view it..

#Profile on LinkedIn

 
Timur Galimov
Chief Technology Officer

Timur has over eighteen years of professional experience at the industry. Timur worked at Global Contract Research Organization as a Lead Software Developer, Head of Data Management Department and IT Director being in charge of IT infrastructure in several countries.

At Flex Databases, Timur performs strategic management of the company, sets the direction of product development, and is responsible for operational activities, project management and the IT system of the company.

Timur obtained a degree in Information Security (St. Petersburg MTU) and completed a post-graduate course in the Department of Data analysis. Along with a technical education Timur obtained a degree in Management, Finance and Accounting.

#Profile on LinkedIn

 
Olga Loginovskaya
MD Chief Quality & Corporate Officer

Olga obtained a degree in medicine at St. Petersburg State Medical University in 1992. Olga has tremendous practical experience in clinical trials gained during 22 years while working in a global CRO at various positions from monitor to vice president.

Now Olga is responsible for client relationship, global sales, corporate growth and strategic development of the company. Olga also participates in startups of new products and new versions development.

#Profile on LinkedIn

 
Alexander Kononov
Chief Product Officer

Alexander is the leading developer at Flex Databases. His unique approach to software design and over 15 years of programming experience, including 6 years as Lead Software Developer at a global CRO, made it possible to develop our platform into a one-stop solution for multiple tasks of the clinical trials industry. Alexander obtained higher technical education at St. Petersburg State Marine Technical University, and is a two-time winner of programming competitions held in the Russian Federation.

#Profile on LinkedIn

 
Natalia Blagodarova
Director, QA Department 

As QA Director, Natalia provides guidance, direction, leadership and governance processes for all initiatives related to Quality Assurance, validation activities, employee and client training.

Prior to joining Flex Databases, Natalia worked in the Training & Quality Management department at a global Contract Research Organization, where she was in charge of quality assurance aspects and training compliance. Natalia holds a Specialist degree from Saint-Petersburg State University.

#Profile on LinkedIn

 
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