Standards and validation.
secuTrial® is designed for conducting clinical trials for the purposes of obtaining licensing approval for medicinal products. It therefore complies with all regulatory requirements in the areas of quality management, software development, FDA/GCP compliance and data privacy.
Fulfilment of regulatory standards
- Compliance with 21 CRF Part11, FDA guidelines on electronic records and electronic signatures
- GCP, Good Clinical Practice, Directive 2001/20/EC
- Standard requirements for GCP-compliant data management in multinational clinical trial, ECRIN (European Clinical Research Infrastuctures Network)
- German Medicinal Products Act
- GAMP5, Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture
Data privacy in secuTrial®
- Personal data or data that can identify a patient is not stored on the server. Patients are identified via a pseudonym.
- Only the treating physician is able to re-identify a patient via a data printout.
- Users can only see data that has been collected in their centre, as ensured by a system of differentiated roles and rights.
- The data is encrypted before it is transmitted to the server.
- secuTrial® complies with FDA 21 CFR Part 11.
secuTrial® fulfils all the necessary requirements for use in clinical trials (Phase II/III) and can be easily validated as a productive system in the respective clinical setting.
Regular and neutral audits of processes and technology
- ABB Eutech, Principal Validation Consultant
- Biomedion expert report for secuTrial 2.1
- proDerm Schenefeld (annual certificate)
- Haapacs GmbH (2013 twice)
- CTCN North (2012, certificate)
- GKM (2014, certificate)
- Center for Pediatric Clinical Studies, Tübingen (2014)
- ZKS and IMISE Leipzig (2016)
- Haapacs GmbH (2016)
… and many more