The process of the development of studies build with the ALEA software is monitored by the Quality Assurance department with an ISO 9001 based Quality Management System (QMS). The core components of monitoring are to ensure patient protection and to validate integrity of the data. It is also to ensure investigators are following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards.
Compliance
General Data Protection Regulation
ISO 27001 Certificied Hosting Facility
ICH – E3
Good Clinical Practice
CFR 21 part 11 (FDA)
''Quality is doing things right when no one is looking''
-Henry Ford
Components of Our Quality Process
Implement Quality Systems
Stock-Taking
Formatting SOP's
Periodic Monitoring
Audits Support
Resource Management
ALEA Clinical and the General Data Protection Regulation
General Data Protection Regulation
A long time before the start of the new General Data Protection Regulation, ALEA Clinical Services created a version of ALEA which is completely in compliance with the GDPR. After that version, there have been several following versions, where are even more security improvements, but also feature requests from our customers. Are you interested in the newest version of ALEA, which of course is completely in compliance with the GDPR? Please contact us at the contact page.