Certified EU ISO/IEC 27001 Systems and Data Processing

An ISO/IEC 27001 Certified Environment for Privacy and Security

Ethical’s approach to quality, compliance, and privacy is simple: be expert, be thorough. That is why our business processes, systems, and services are compliant with all appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).

Ensuring Compliance

The software we design and the services we provide are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 Information Security Management System (ISMS) requirements and security controls. It is a rigorous, systematic approach to managing sensitive information by applying a risk management process to all information touchpoints: people, processes, and systems. Ethical and its parent company, GM Servizi srl, ensure the performance and provision of:
  • Formal asset and risk assessments;
  • Business continuity and disaster recovery;
  • Logical and physical access controls
  • Security and prevention
  • Backup and restore SOPs
  • Periodic internal audits

Ethical' Commitment to You

Every Ethical portal and software package offered primarily as services are developed, released, and maintained in conformity with

ISO/IEC 27001 procedures and SOPs for good practice, prevention, and management
Security controls for physical and logical access to premises, equipment, services, and information
Confidentiality controls on customers' information and data, including EU GDPR compliance
Integrity and availability of services geographical monitoring
Constant employee training on possible informatic vulnerabilities and threats


Download Your DSMB-DMC Complete Handbook

We are EU-GDPR compliant: Your Data will never be used improperly

eDSMB Dossier

software solution
service description

Previous Next

Data Monitoring Committees (DMC) and Data Safety Monitoring Boards (DSMB) Definitions, Procedures and Tools

Terms and definitions related to Data Monitoring Committees and Data Safety Monitoring Boards

dsmb definitionsREAD MORE

FDA/EMA Guidance Documents on Data Safety Monitoring Boards

Establishment and Operation of clinical trial Data Monitoring Committees and Data Safety Monitoring Boards – Helpful links to the FDA and EMA Guidance Documents.

dsmb regulationsREAD MORE