EDC

Flex EDC is a fully integrated, all-in-one Electronic Data Capture system designed to accelerate clinical trials for sponsors, CROs, investigator sites, and patients. Built for scalability, the platform supports studies of up to 500,000 subjects and is ready to launch in as little as three weeks with expert onboarding. Flex EDC combines core EDC functionality with built-in RTSM, Risk-Based Monitoring (RBM), and ePRO capabilities — eliminating the need for third-party integrations — while maintaining compliance with 21 CFR Part 11, GCP E6 R2, HIPAA, and GAMP5.

The platform leverages AI-powered automation for medical coding, reducing manual effort and errors, and supports global trials through multilingual study configurations and multilingual patient surveys. With real-time dashboards, audit-ready data exports, and version-controlled documentation, Flex EDC is engineered to deliver smarter, faster clinical trial outcomes.

eCRF Design and Study Build

• Build eCRFs visually using drag-and-drop tools, templates, and logic — no coding required
• Apply adaptive design, triggers, and hidden forms to handle complex study requirements
• Preview and validate forms instantly using a built-in test mode
• Update workflows mid-study without IT support or system downtime
• Maintain version control for protocols, consents, and key study documents throughout the trial

Site and Investigator Tools

• Navigate an intuitive interface designed to minimise training time for site staff
• Customise dashboards by role for targeted oversight and efficient data management
• Manage subject enrolment and visit schedules with smart planning tools and a per-subject visit calendar
• Reduce site burden using autofill fields, auto-calculations, and prebuilt query templates
• Track enrolment progress and data quality in real time using a semaphore system for quick process assessment
• Resolve queries quickly using prebuilt templates and simple one-click subject navigation

Built-In RTSM (Randomisation and Trial Supply Management)

• Support block, stratified, minimisation, or fully custom randomisation schemes
• Control drug inventory and trigger automated resupply workflows
• Adapt randomisation parameters mid-study without downtime or disruption

Patient Engagement with ePRO

• Deploy branded mobile and web applications with offline access for patient diary entry
• Trigger ePRO forms through EDC edit checks for seamless, connected data flow
• Send smart reminders to improve patient compliance and engagement
• Capture rich patient-reported data via wearable device integrations (e.g. fitness trackers, smartwatches) and multilingual surveys

Risk-Based Monitoring and Reporting

• Visualise KPIs and study metrics across the entire trial through real-time dashboards
• Detect anomalies using 26+ risk signals and fraud indicators
• Customise reports for internal teams and regulatory submissions
• Export clean, audit-ready data instantly in CDISC SDTM, SAS, and XML formats
• Generate annotated eCRFs and submission-ready exports in a single click

Compliance and Medical Coding

• Automate medical coding with AI across WHODrug, MedDRA, ATC, and ICD dictionaries
• Manage protocols, consents, and regulatory files with full version control
• Maintain compliance with 21 CFR Part 11, GCP E6 R2, HIPAA, and GAMP5 standards
• Generate annotated eCRFs and submission-ready data packages on demand

Role-Based Capabilities for Every Stakeholder

• Sponsors and CROs: Monitor trial progress with semaphore tracking, assign predefined or custom roles, export data instantly to meet submission deadlines, and oversee documentation with version control at every stage
• Sites and Investigators: Access the system through a dedicated investigator portal, validate entries using auto-calculations and logic, enrol subjects, manage visit schedules, and resolve queries using prebuilt templates
• Patients: Use app-based diaries for daily data entry, receive timely reminders, complete multilingual surveys, and sync data instantly with the study backend

Flex EDC is a cloud-based platform trusted by 100+ clients across 30+ countries, supporting over 2,000 clinical trials and 20,000 daily users. The system is validated and certified for regulatory compliance and integrates seamlessly within the broader Flex Databases suite, which includes CTMS, eTMF, DMS, Pharmacovigilance, and Project Management and Budgeting modules.