About
About us
Flex Databases is a team of professionals that will help you run clinical trials more effectively
 
Flex Databases Specialists have extensive experience and a strong background in clinical trials which resulted in a product that was completely customized to our specific 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 a global IT vendor specialized in developing comprehensive software solutions specifically for business process management in the Clinical Trials industry on a global scale. Today we are proud to count top Contract Research Organizations (CROs) and Pharmaceutical Companies in Europe, Asia, and the United States among our clients.

2005

 

In 2005, we developed our first universal business application specifically for a CRO. Using our knowledge and experience gained from our work in the financial sector, we gradually adapted our platform to meet the specific needs of companies performing clinical trials. As we developed our platform further, we came to the conclusion that the pharmaceutical industry was lagging behind other industries in adopting the platform approach. Our platform is the perfect match for both CROs and companies working in pharmaceutical development and thus led to our shift, 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 over 80 professionals who possess a deep understanding of the clinical trial process made it possible to create a flexible platform that combines solutions for general management (HR, timesheets, workflow management, budget & project management, Learning Management System, expense reporting) and solutions specifically developed to simplify business process management in clinical trials (CTMS, EDC, Trial Master File).

Clients
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 any client and seamlessly integrated with legacy systems.

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

Every Flex Databases system is compliant with FDA requirements (Part 11 of Title 21 of Code of Federal Regulations, U.S. Department of Health and Human Services; 21 CFR Part 11), including:

  • Safe electronic records storage, quick and accurate retrieval throughout the entire period of their retention
  • Automatically generated audit trails which record the time and date of each entry and action performed by any system user
  • Credential verification to ensure that only authorized individuals can use the system in accordance with their access rights
  • Operational system checks to enforce permitted sequencing of steps and events in the system
  • Password aging and other privacy processes to ensure the highest level of security for your data
  • Electronic signature protocols to provide integrity between the record and the signature attached 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

Our system can be readily integrated with a number of industry-standard 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 efforts and timelines.

Hosting

One of the most important aspects of our work alongside our ability to multitask while remaining flexible to change and attentive to our customers' needs is the reliability of our data storage and the uninterrupted access to our services. We use the latest failsafe technology in order to ensure unwavering accessibility and impassable data security.

  • Only certified data centers
  • Reliable hardware
  • Virtualization
  • Clusterization
  • Data storage on a 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 any client and seamlessly integrated with legacy systems.

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

Every Flex Databases system is compliant with FDA requirements (Part 11 of Title 21 of Code of Federal Regulations, U.S. Department of Health and Human Services; 21 CFR Part 11), including:

  • Safe electronic records storage, quick and accurate retrieval throughout the entire period of their retention
  • Automatically generated audit trails which record the time and date of each entry and action performed by any system user
  • Credential verification to ensure that only authorized individuals can use the system in accordance with their access rights
  • Operational system checks to enforce permitted sequencing of steps and events in the system
  • Password aging and other privacy processes to ensure the highest level of security for your data
  • Electronic signature protocols to provide integrity between the record and the signature attached 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.

Our system can be readily integrated with a number of industry-standard 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 efforts and timelines.

One of the most important aspects of our work alongside our ability to multitask while remaining flexible to change and attentive to our customers' needs is the reliability of our data storage and the uninterrupted access to our services. We use the latest failsafe technology in order to ensure unwavering accessibility and impassable data security.

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

 

Olga Loginovskaya
MD Chief Quality & Corporate Officer

Olga earned a degree in medicine at St. Petersburg State Medical University in 1992. Olga has vast practical experience in clinical trials that she gained during her 22 years working at a global CRO in a series of positions ranging from monitor to Vice President.

Now Olga is responsible for the corporate growth and the strategic development of Flex Databases. Olga also participates in the release process of new products and supervises the development of the latest versions of our system.

#Profile on LinkedIn

 

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