What Flex Databases does

Flex Databases is a privately held software company founded in 2011 in Prague, Czech Republic, that builds a unified, cloud-hosted eClinical SaaS platform for the life sciences industry. Its product surface spans a Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) with a dedicated Investigator Site File (ISF) module, Electronic Data Capture (EDC) with integrated RTSM and ePRO, a Document Management System (DMS), Project Management and Budgeting, Pharmacovigilance, and a combined Learning Management and Quality Management System (LMS/QMS). The platform is built on Microsoft ASP.NET Web Forms with Firebird database back-end and DevExtreme/DevExpress UI components, deployed from EU and US cloud data centers, and is designed for end-user no-code/low-code configuration. A proprietary AI capability — multimodal (text and image) document classification with explainable reasoning — is embedded in the TMF module, reporting 65% out-of-box automation rising above 80% after client-specific tuning.

The company serves pharmaceutical, biotechnology, medical device, and academic research organizations as well as Contract Research Organizations (CROs), with CROs and sponsors each comprising roughly half of the active client base of 100+ organizations across 30+ countries. Commercial model is enterprise SaaS with quote-based annual subscriptions, demo-led enterprise sales cycles, dedicated project managers assigned per client, and implementation typically completed within 3 to 10 weeks. Distribution is direct (no public pricing), supported by industry-conference participation and a content-marketing blog. Compliance posture covers FDA 21 CFR Part 11, ICH GCP E6 R2, GAMP 5, GDPR, HIPAA, ISO 27001 (certified December 2024), and ISO 9001:2015 (certified June 2024).

Operations span four offices — Prague (headquarters), Princeton NJ, Lausanne, and Antalya — with named enterprise and mid-market customers including Novo Nordisk, Dr. Reddy's, Ergomed PLC, BIOTRONIK, CMIC HOLDINGS, Bioxcel Therapeutics, MapLight Therapeutics, Immutep GmbH, Agenus, FGK Clinical Research, Harbor Clinical, and ABX-CRO. The company remains bootstrapped and owned by its working managers, led by CEO Olga Loginovskaya and CTO/co-founder Timur Galimov, with no disclosed external institutional investment.

Name

Flex Databases

Legal name

Flex Databases s.r.o.

Website

https://flexdatabases.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

101–250 employees

Short description

Flex Databases is a private SaaS provider of a unified eClinical platform (CTMS, eTMF, EDC, pharmacovigilance, QMS) serving pharmaceutical, biotech, MedTech, academic, and CRO organizations globally, with embedded AI-powered document classification.

Ownership category

akta.pro rank

Product category

Clinical Trial Management Software

NAICS

Computer Systems Design and Related Services (54151), Custom Computer Programming Services (541511)

SIC

Services-Computer Programming, Data Processing, Etc. (7370), Services-Prepackaged Software (7372)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Electronic Data Capture (EDC) Platforms (HLACAOAA), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG)

Keywords

• Clinical trial software
• EClinical platform
• Trial master file
• Clinical data capture
• Pharmacovigilance software

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Infrastructure, Marketing or Sales, Operations

Revenue model

1. SaaS Platform Subscription: Flex Databases delivers its eClinical platform as a hosted SaaS solution. Customers pay for access to the platform and its modules under contractual agreements. Delivery is typically SaaS with applications hosted in cloud data centers managed by Flex Databases. Implementation, validation support, and training services are included as part of the customer engagement, with the primary revenue stream being recurring platform subscription fees.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Flex Databases provides a unified, cloud-hosted SaaS eClinical platform for life sciences organizations to manage clinical trials end-to-end. The platform combines CTMS, eTMF, EDC (with built-in RTSM and ePRO), DMS, Project Management & Budgeting, Pharmacovigilance, and LMS/QMS modules, with AI-assisted document classification, no-code configurability, and full regulatory compliance (FDA 21 CFR Part 11, ICH GCP E6 R2, GDPR).

Product overview

Flex Databases offers a unified eClinical platform composed of integrated modules for managing clinical trials, documents, quality, and people. The core platform includes CTMS (Clinical Trial Management System) for operational trial oversight, eTMF (Electronic Trial Master File) for document management, and EDC (Electronic Data Capture) with built-in RTSM and ePRO. These are supplemented by dedicated modules: DMS (Document Management System), Project Management & Budgeting, Pharmacovigilance, and the combined LMS & QMS (Learning Management System & Quality Management System). The platform operates as a SaaS solution delivered via cloud infrastructure, enabling cross-functional data integration and workflow automation across clinical operations.

Differentiator

Problem solved

Functional benefit

Products and services

• CTMS (Clinical Trial Management System) Comprehensive clinical trial management platform enabling real-time management of CRA activities, patient data, site operations, and invoicing. Includes scheduling of monitor visits, CRA performance assessment, visit report generation, online invoicing, payment rules, site budget management, and centralized storage for investigator, site, vendor, and therapeutic area information. Designed for pharmaceutical companies, biotech firms, CROs, MedTech, and academic research institutions running clinical trials.
• eTMF (Electronic Trial Master File) Electronic Trial Master File system providing secure, instant access to trial documentation from anywhere. Ensures constant audit readiness with real-time visibility into document status, quick uploads, missing file identification, and real-time review and correction capabilities. Includes AI-powered document classification and a dedicated ISF (Investigator Site File) module with separate views for Sponsors, CRAs, and Sites. Designed for clinical trial sponsors and CROs managing regulatory documentation.
• EDC (Electronic Data Capture) Electronic data capture system with integrated RTSM (Randomization and Trial Supply Management) and ePRO (electronic Patient-Reported Outcomes). Features rapid study build and deployment, clean intuitive interface for sites and investigators, built-in randomization and supply management, and real-time patient data collection. Built for sites, investigators, sponsors, and CROs running clinical studies.
• DMS (Document Management System) Document management system for organizing, storing, and managing clinical trial documentation. Provides centralized document repository capabilities with version control and access management for clinical trial sponsors and CROs.
• Project Management & Budgeting Project planning and resource allocation module enabling management of unlimited projects with workload tracking, automated reporting for performance analysis, and centralized expense management across all project-related activities. Designed for CROs and sponsors managing multiple clinical trial projects.
• Pharmacovigilance Pharmacovigilance module ensuring compliant PV activities throughout all trial stages with centralized management of adverse event tracking, safety reporting, and regulatory compliance processes. Designed for clinical trial sponsors and CROs responsible for safety data management.
• LMS & QMS (Learning Management System & Quality Management System) Combined learning and quality management system covering SOP management, audits, incidents, CAPA, and quality-related activities. Includes automated employee onboarding with assigned training, advanced knowledge level reporting, QMS document control with revision history and electronic signatures, and KPI tracking at company and project levels. Designed for life sciences organizations needing GxP-compliant training and quality processes.

Quantifiable outcome

• Large sponsor managing 100,000 documents/year saves ~6,600 hours and ~€267,000 annually through AI-assisted TMF filing at 80% automation
• +2 more outcomes

Named customers17 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability6 records

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• MapLight TherapeuticscoreStrategic or Co-development Partner · 26 March 2026MapLight Therapeutics selected Flex Databases as its primary provider for Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions. The integrated platform will replace disparate systems to reduce administrative burden, ensure GDPR compliance, and provide real-time data access for study oversight from startup to closeout. MapLight selected Flex Databases based on the platform's configurability, automated document management features, and potential for a long-term strategic partnership. The collaboration is framed as a strategic long-term investment.
• Immutep GmbHcoreStrategic or Co-development Partner · 10 March 2026Immutep GmbH partnered with Flex Databases to implement the Flex Databases eTMF solution for digitizing clinical trial documentation management across its ongoing studies. The implementation replaced a previous paper-based Trial Master File system that had caused bottlenecks and limited real-time visibility. The eTMF solution has streamlined document management, enhanced audit workflows, and improved collaboration with external partners including CROs. Selection criteria focused on regulatory compliance with 21 CFR Part 11 and cost transparency.
• BIOTRONIKcoreStrategic or Co-development Partner · 30 November 2025BIOTRONIK selected Flex Databases as its global eClinical partner to support clinical trial operations and digital transformation. The company aims to improve reporting, oversight, and regulatory compliance through adoption of the unified platform, moving from a customized internal system to a SaaS environment.

Scale indicators5 records

Recent moves1 record

Expansion highlights6 records

Emerging players

• OpenClinica: Open-source and cloud EDC, ePRO, and clinical data management platform serving academic, biotech, and CRO customers. Emerging competitor to Flex's EDC and data capture capabilities, especially in cost-sensitive academic and mid-market accounts.
• Castor EDC: Cloud-native EDC and eClinical platform targeting academic and emerging biotech sponsors with rapid-deployment capabilities. Emerging competitor to Flex's EDC module with a stronger focus on decentralized and hybrid trial designs.
• Florence Healthcare: Site-focused eISF and eTMF connectivity platform enabling document exchange between sponsors, CROs, and investigator sites. Partial overlap with Flex's ISF module and complementary in site-centric TMF workflows.

Direct peers

• Ennov: Provider of CTMS, eTMF, QMS, and regulatory document management solutions for life sciences, including a strong QMS offering comparable to Flex's LMS & QMS module. Direct peer particularly in the European mid-market segment.
• Medidata Solutions (Dassault Systèmes): Provider of Rave EDC, Rave CTMS, eCOA, and RTSM platforms widely used in clinical trials globally. Competes head-to-head with Flex Databases' EDC, CTMS, and ePRO offerings for enterprise and mid-market sponsors and CROs.
• Veeva Systems: Dominant cloud-native life sciences SaaS provider with Vault CTMS, Vault eTMF, Vault EDC, and Vault Safety suites serving global pharma and biotech. Directly comparable to Flex Databases across all core eClinical modules and enterprise buyer segments.
• Calyx: Provider of EDC, IRT/RTSM, CTMS, and eTMF solutions with deep penetration in biotech and CRO segments. Closely comparable to Flex Databases across EDC and trial management offerings and similar mid-market buyer focus.
• ArisGlobal: LifeSphere platform provider covering CTMS, eTMF, pharmacovigilance, and regulatory affairs for pharma and CROs. Direct peer with strong overlap in PV, CTMS, and eTMF and similar mid-market and CRO customer mix.

Broad incumbents

• Oracle Clinical One: Oracle's eClinical platform spanning EDC, CTMS, and randomization, built on acquired InForm/Phase Forward technology. Competes across enterprise pharma and is one of the entrenched incumbents Flex must displace to grow at the high end.
• Veeva Vault Safety / Oracle Argus: Pharmacovigilance and safety case management incumbents (Vault Safety, Oracle Argus) competing with Flex's Pharmacovigilance module. Broad incumbents with safety databases deployed across most large pharma, setting the standard Flex must match for PV buyer qualification.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/flexdatabases
• Facebookfacebook.com/flex-databases-1635133430087010
• LinkedInlinkedin.com/company/flex-databases

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Flex Databases