Use in clinical studies
EDC systems (Electronic Data Capture) have become a valuable tool for the development of medicinal products and offer many advantages when conducting clinical studies.
secuTrial® is a powerful, web-based software solution for clinical trials. It enables patient data for clinical multi-centre studies to be collected and managed entirely via the Internet. Full compliance is ensured with all licensing and data privacy regulations while guaranteeing the highest quality standards.
secuTrial® offers a high degree of conceptual freedom with regard to study design, flexibility and user friendliness. It can therefore be used in a variety of ways for all clinical trial phases, such as clinical trials for licensing approval or phase IV studies.
Electronic signatures, a randomization function and the workflow for managing (serious) adverse events are just a few of thesecuTrial® features that make it an ideal solution for clinical studies.
Advantages of secuTrial® for clinical studies
- Solution developed over many years, reliably proven in practice
- Streamlined solution for study management and data collection
- Simple study setup
- High data plausibility
- Simple validation to 21CFR, Part11
- Secure and independent data collection via the Internet (SSL)
- Entirely web-based (no software installation required)
- Study-specific generation of eCRFs (electronic case report forms)
- FDA-compliant data collection (AuditTrail, E-signature etc.)
- Pseudonymisation of personal data in compliance with data privacy regulations
- Scalable system of roles and rights, password protected access
- Comprehensive query management
- Central database (Oracle 9.i)
- Customer-oriented product development and refinement
- Attractive price model
- High investment security, future-proof solution