secuTrial

secuTrial is a browser-based Electronic Data Capture (EDC) system developed by interActive Systems Berlin for use in clinical trials, non-interventional studies, and patient registries. It supports data collection via electronic Case Report Forms (eCRFs) and is designed to comply with GCP standards, FDA requirements, and CDISC data models. The system has been in use since 2000 and has been deployed in more than 600 national and international studies across university institutions, CROs, medical device manufacturers, and pharmaceutical companies.

secuTrial is intended for study administrators and investigators who need a study setup process that does not require programming knowledge. All that is required to operate the system is a browser and an internet connection. The platform supports pseudonymised image management (including DICOM format) and offers differentiated licensing models, optional hosting, and CRO full-service options.

Core Features and Capabilities

• Fully browser-based EDC system requiring no local software installation
• eCRF creation and study setup without programming skills
• GCP-compliant and fully FDA-compliant (21 CFR Part 11)
• Support for CDISC data models via standardised import and export interfaces
• Pseudonymised image management, including DICOM format
• Seven built-in randomisation algorithms supporting multiple treatment arms, with options for unblinded, single-blind, and other configurations
• Double Data Entry support to reduce input errors when paper-based documentation is also used
• Secure storage of patient email addresses to enable automated visit reminders (introduced in version 6.8.3.4)
• Patient-reported outcome (PRO) capture via mobile patient apps, with each app tailored to the specific study and target group
• A base patient app providing core PRO functionality via smartphone

Quality and Compliance

• Developed for use in approval-relevant drug trials
• Complies with GCP, 21 CFR Part 11, and additional regulatory standards
• New functions are verified by independent testers as part of a qualified change management process, covering requirement checks against specifications and early defect detection
• Validation processes align with EMA guidelines on computerised systems and electronic data in clinical trials

Deployment and Scale

• More than 100 customer installations
• More than 1,000 projects completed
• More than 3,000 study centres connected
• More than 14,500 users
• More than 250,000 patients recorded
• Optional hosting available through a data centre operated by noris-network AG in Nuremberg

User Community and Support

• Annual user meetings held in Berlin, combining workshops, symposia, and networking; available both in-person and as video conference
• Training programmes offered, including eCRF creation, data entry, validation, and data export
• Used in academic teaching at Hochschule Hannover for the Medical Information Management degree programme
• Customers include university medical centres, CROs, pharmaceutical companies, and medical device manufacturers

secuTrial is offered with flexible licensing models suited to different budget requirements. Service options include direct support contacts, optional hosting, and CRO full-service arrangements. The system has been used in international contexts, including studies conducted in Nigeria and Switzerland, and has been in continuous development since 2000.