Our Goal

The process of the development of studies build with the ALEA software is monitored by the Quality Assurance department. 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.

Jolanda Remmelzwaal – Quality Assurance Manager

Components of Our Quality Process

Implement Quality Systems
Stock-Taking
Formatting SOP's
Periodic Monitoring
Audits Support
Resource Management
''Quality is doing things right when no one is looking''
-Henry Ford

Certifications

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Audits
ISO 27001 Certificied Hosting Facility
ICM – E3
Good Clinical Practice
CFR 21 part 11 (FDA)
Upcoming Certifications for 2018:
General Data Protection Regulation