EDC

TrialStat EDC is a cloud-based Electronic Data Capture suite designed for clinical trials across all phases, including pilot and proof-of-concept studies, Phase I through IV, as well as medical device and diagnostics studies. The platform is built as a fully unified, single-sign-on, multi-tenant system that consolidates data capture, randomization, safety management, patient reporting, imaging, and analytics into one environment. It is suited for sponsors, CROs, and research teams seeking to manage clinical data without relying on multiple disconnected third-party systems.

TrialStat EDC connects to external data sources including EMR/EHR systems, validated medical wearable devices, local and central labs, and other EDC platforms. Data can also be pushed outbound to systems such as CTMS, eTMF, and safety platforms. The platform is browser-based and mobile-responsive, accessible from any device without proprietary plugins or desktop software installations. Infrastructure is powered by PureStorage FlashArray. The system has been used in over 500 clinical trials, with 96% of studies launching on time and database lock achieved within 10 days in more than 92% of studies.

Core Modules and Capabilities

• eConsent: Supports configurable consent workflows including witness consent, assent, re-consent, and patient revocation of consent. Fully integrated with TrialStat EDC but can also operate alongside other EDC platforms.
• Electronic Patient Reported Outcomes (ePRO / eCOA): Integrates patient-reported data directly with site data, eliminating the need for a separate third-party ePRO system. Supports full eCRF capabilities, multi-language localization, customized patient interfaces, and visit notification windows.
• Randomization / IWRS: Provides integrated IWRS functionality supporting any degree of randomization complexity. Sites can trigger randomization codes directly within TrialStat EDC without requiring a separate software system.
• Medical Coding: Supports coding activities using WhoDrug, MedDRA, and custom dictionaries directly within the EDC. Users select the desired dictionary and version and apply it to a specific eCRF field.
• Pharmacovigilance – AEs and SAEs Management: Included as part of the suite for adverse event and serious adverse event tracking and management.
• Vendor Neutral Imaging Archive (VNA): Developed in partnership with Fuji Film / Teramedica, the VNA captures imaging at the site level, de-identifies files, and routes them to a core lab for review. Supports imaging adjudication within clinical trials and post-trial access to imaging assets. Includes an HTML5-compliant DICOM viewer that is CE Class IIa certified.
• Clinical Data Warehouse: Stores current and historical clinical trial data to support meta-analysis across studies and integration with machine learning programs.
• Machine Learning and AI: Covers applications from drug discovery and adaptive clinical trial support to safety signalling. Custom program development is available, as is integration of validated third-party machine learning programs for clinical and imaging data.
• Third-Party Systems Integration: Supports data ingestion from EMR/EHR systems, wearables, other EDC platforms, and labs, as well as data export to CTMS, eTMF, and safety systems.

Platform Features

• Completely customizable eCRFs with dynamic skip logic and comprehensive edit checks
• CDASH-compliant CRF library
• eSource data capture
• Configurable study workflow
• Inventory management and barcode integration
• Real-time monitoring, reporting, and validation
• Over 40 standard reports plus configurable reports and dashboards
• Interactive drill-down reporting and real-time data visualization
• Multi-lingual support
• Ability to replicate entire studies
• Flexible data capture including real-world data integration
• Image management capabilities
• Typical database build time of 2–4 weeks

Available Services

• Study design and configuration
• Project management
• End-user training
• Rescue studies
• Randomization and supply management
• Custom software development and validation, including compliance with 21 CFR Part 11, HIPAA, and Privacy Shield

TrialStat EDC is scalable across research portfolio sizes and supports CRO partnerships. Custom development services are available for sponsors requiring bespoke technology implementations, integrations, or novel machine learning programs tailored to specific study challenges.