Flex Databases

Flex Databases builds eClinical software for life sciences organizations—CROs, pharma, biotech, and medical device companies—to manage the full lifecycle of clinical trials. Founded in 2011 in Prague and still privately owned, the company now operates offices in Switzerland, the United States, and Turkey. The platform serves over 100 clients across 30+ countries, managing 2,000+ clinical trials, 10M+ documents, and supporting 20,000+ daily users. Flex Databases doesn't build point solutions; it builds a unified system covering CTMS, eTMF, EDC, pharmacovigilance, project management, and quality/learning management in a single instance.

Services and capabilities

Flex Databases' core offering is modular but integrated. The CTMS handles CRA activities, patient data, site management, and investigator invoicing in real time. It allows users to schedule monitor visits, assess CRA performance, and generate custom reports. The eTMF module provides centralized access to trial documentation with audit-trail tracking; users upload documents, flag missing files, and verify compliance instantly. The EDC system includes built-in randomization, trial supply management (RTSM), and patient-reported outcomes (ePRO). The PM & Budgeting module manages resource allocation, project tracking, and expense management across unlimited projects. Pharmacovigilance covers all PV processes within the system, including EDI gateway communication with regulatory authorities and custom report generation. The LMS & QMS handles SOPs, audits, incidents, corrective and preventive actions (CAPA), personnel qualification, and employee onboarding with automatic training assignment.

The platform emphasizes configuration over customization—users can tailor most modules themselves without IT intervention. Implementation typically takes 3 to 10 weeks depending on client involvement. Flex Databases handles system rollout, data hosting, backups, security, and validation throughout the engagement.

Compliance and security

The company is compliant with ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, GCP, GMP, and HIPAA. It maintains distributed data storage around the world and a documented backup and disaster recovery strategy. The company has participated in numerous regulatory audits and has supported clients during FDA inspections.

Notable work

Clients include FGK Clinical Research, NCGS (which deployed nearly Flex's entire suite of modules), Agenus, Harbor Clinical, CMIC Holdings (APAC operations), and more recently MapLight Therapeutics, Immutep, BIOTRONIK, and SOLTI. The source material indicates that Agenus described its CTMS and TMF implementation with Flex as "the smoothest and fastest implementation of a validated IT system we have done" over the company's 26-year history. BIOTRONIK selected Flex Databases following a rigorous evaluation, citing broad functionality, competitive pricing, and strong ROI. One client noted that they valued the ability to create custom reports themselves and that Flex Databases takes feature requests seriously and incorporates them into the product roadmap.

How they work

Flex Databases operates a demo-first sales process. Prospects speak with an expert, receive a tailored live demonstration, and then negotiate implementation timelines. The company emphasizes customer collaboration over contract negotiation and works with organizations of all sizes—small biotech startups and global enterprises alike. Implementation timelines range from 3 to 10 weeks. Support includes on-site and remote training, configuration assistance, and ongoing compliance support. The company is privately owned by working managers, which influences its stated focus on transparency and personality over formality.

Team and credentials

Founded in 2011, Flex Databases remains privately owned. The company has offices in Prague (HQ), Lausanne, Antalya, and Princeton, NJ. Team size is not disclosed in the source material. The platform is GDPR, HIPAA, GCP, GMP, and FDA 21 CFR Part 11 compliant. Flex Databases has demonstrated compliance across numerous regulatory audits and client inspections.