Use in non-interventional studies
The quality of the data collected in practice with as large a patient cohort as possible is becoming increasingly important in non-interventional studies (NIS), in particular due to the growing regulatory requirements.
The web-based solution secuTrial® makes it easy to carry out all types of NIS – including observational studies and therapeutic drug monitoring – and ensure a high level of data quality. Instead of traditional case report forms, electronic forms are used which are easy to fill out and use. All that the clinical investigator requires is a browser and Internet access.
In addition to electronically implementing the observation plan, we also offer you the option of handling your entire NIS in cooperation with our reliable partners. On request, we can cover everything from the initial planning and conceptual design through to implementation, administration, biometric analysis, site payment and the production of final reports, individual physician reports and publication manuscripts.
Case example: observational study
For a high-selling clinical preparation, a post-marketing study was commissioned to provide meaningful results showing the product’s value in practice. The study was designed as a purely EDC-based solution using secuTrial®. Every 3 months, the participating clinical investigators received a detailed benchmarking analysis of their treatment results compared to all other participants, providing insights for optimising their treatment strategies.
Case example: long-term observational study
Data was needed on an innovative pharmaceutical drug used for a vital indication in order gather national experiences with long-term therapy in practice. The strategic objective of the study was to identify predictive patient criteria for successful response to the therapy. The data collection for the three-year study was carried out withsecuTrial®. A partner CRO managed the study including participant administration and biometrics.
Advantages of secuTrial® for non-interventional studies
- Solution developed over many years, reliably proven in practice
- Optimal study control
- High quality study data
- 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
- Price model independent of number of cases
- High investment security, future-proof solution