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Company description

secuTrial® is a fully browser-based, GCP-compliant Electronic Data Capture (EDC) system developed for collecting patient data via eCRFs in clinical trials, non-interventional studies, and patient registries. The platform has been in use since the year 2000 and has been deployed in more than 600 national and international studies and long-term projects. It serves a broad range of organisations including university institutions, contract research organisations (CROs), medical device manufacturers, and pharmaceutical companies.

The system is designed to allow study setup and eCRF creation without programming knowledge, relying on an intuitive user interface that requires only a browser and internet connection for both administrators and investigators. secuTrial® supports pseudonymised image management (including DICOM format), standardised import and export interfaces such as CDISC data models, and is fully FDA-compliant. The company offers differentiated licensing models, optional hosting, and CRO full-service support.

Core Capabilities

  • Fully browser-based EDC system requiring no local software installation
  • Self-service study setup and eCRF creation without programming skills
  • Pseudonymised image management, including support for DICOM format
  • Standardised data import and export interfaces, including CDISC data models
  • GCP compliance and full FDA conformity
  • Support for clinical trials, non-interventional studies, and patient registries
  • Direct patient communication: from version 6.8.3.4, real patient email addresses can be stored securely, enabling automated visit reminders
  • Mobile patient apps for the collection of Patient Reported Outcomes (PRO), each tailored in design and user guidance to the specific study and target group

Key Advantages

  • Wide range of application scenarios across study types and organisations
  • User-friendly operation for both administrators and clinical staff
  • High quality standards with a proven track record since 2000
  • Customer-oriented service with local points of contact
  • Flexible and budget-compatible licensing models
  • Optional hosting services and CRO full-service offerings
  • Long-term investment security demonstrated by sustained use across hundreds of studies

Deployment and Customer Base

  • Used in more than 600 national and international studies and long-term projects
  • Customers include university medical centres (e.g. Medizinische Hochschule Hannover, Charité Berlin), oncology information services, competence networks (e.g. Kompetenznetz Parkinson), and CROs
  • The KKS Charité reports use across more than 20 studies
  • The platform has been in continuous use by some customers since 2003

Community and Events

  • secuTrial® holds an annual user meeting and symposium in Berlin, now in its 18th edition (2025), offered as both in-person and video conference format
  • Workshop topics have included secuTrial® validation and the EMA guideline on computerised systems and electronic data in clinical trials
  • The company participates in external events such as the DVMD spring symposium, covering topics including ePRO, big data, and risk-based monitoring

secuTrial® is developed and supported by iAS (internet-based Application Solutions), a German agency specialising in medicine and pharma, providing software, hosting, and service for internet-based clinical research.

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