Flex Databases

Flex Databases is a life sciences software platform designed to manage clinical trials, documents, quality, and people within a single integrated system. Founded in 2011 and trusted by market leaders across more than 30 countries, the platform serves sponsors, CROs, and academic organizations seeking a unified eClinical solution. With over 100 clients, 20,000+ daily users, 10 million+ documents managed, and 2,000+ clinical trials supported, Flex Databases has established a strong track record in the industry.

The platform is delivered as a fully cloud-based, no-installation-required solution that end users can configure themselves. Flex Databases can be implemented in as little as 3 to 10 weeks depending on client requirements and involvement, making it one of the faster validated IT system deployments available in the market.

Key Products and Modules

• CTMS (Clinical Trial Management System): Manage all CRA activities, patient data, sites, and invoicing in real time. Features include scheduling monitor visits, assessing CRA performance, generating visit reports, setting up online invoicing, configuring payment rules and site budgets, and organizing information on investigators, sites, vendors, and therapeutic areas in one place.
• eTMF (Electronic Trial Master File): Provides complete visibility into all trial documentation with instant, secure access from anywhere in the world. Ensures constant audit readiness, allows rapid document uploads, identifies missing files, and enables real-time review and correction.
• EDC (Electronic Data Capture): An all-in-one EDC solution with built-in RTSM, ePRO, and full compliance. Enables rapid study build and deployment, offers a clean and intuitive interface for sites and investigators, includes fully integrated randomization and trial supply management, supports real-time patient-reported outcomes, and is designed for every stakeholder involved in a trial.
• Project Management & Budgeting: Simplifies the financial and operational aspects of clinical projects. Allows planning and allocation of resources and workload across an unlimited number of projects, tracks and analyzes project performance through automated reporting, and centralizes all project-related expenses.
• Pharmacovigilance: Supports robust and compliant pharmacovigilance activities throughout all stages of a clinical trial, consolidating all PV processes within a single system and enabling inspection-ready safety data management.
• LMS & QMS (Learning Management System & Quality Management System): Manages all quality-related activities and personnel qualification levels. Covers SOPs, audits, incidents, CAPA, and other quality activities. Facilitates easy onboarding of new employees with automatically assigned training and provides advanced reporting on employee knowledge levels.

Core Platform Capabilities

• Easy Implementation: Fully functional systems can be delivered within 3 to 10 weeks, depending on client involvement and requirements.
• Complete Data Safety: Robust backup and disaster recovery strategy, customer data protection, and distributed data storage locations around the world.
• Full Compliance: The platform is compliant with all major international and local regulations including ICH GCP E6 R2, FDA 21 CFR Part 11, and GDPR.
• Flexible and Configurable: Every part of the proprietary platform can be easily configured by end users with no installation required.

Client Feedback and Notable Customers

• FGK Clinical Research selected Flex Databases for CTMS and TMF, citing its clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and strong cooperation with the Flex Databases team.
• Agenus Inc. described their Flex CTMS and TMF implementation as the smoothest and fastest implementation of a validated IT system in over 26 years of company history.
• NCGS, Inc. has adopted nearly the entire suite of Flex Databases cloud-based modules, aligning with their ideals of uniformity and simplicity in operations.
• Harbor Clinical highlighted the platform's validated, flexible pharmacovigilance capabilities as critical to staying inspection-ready across both small and growing PV portfolios.
• CMIC HOLDINGS Co., Ltd. praised the system's flexibility, user-friendliness, and the team's adaptable approach to client needs.
• Multiple clients have noted that Flex Databases takes feature requests seriously and incorporates them into the development roadmap, as well as offering customer-specific configuration services.

Flex Databases offers a comprehensive, compliant, and highly configurable platform purpose-built for the life sciences industry, enabling organizations of all sizes to streamline clinical operations, ensure regulatory readiness, and manage their entire trial lifecycle from a single system.