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Home / GxP Compliance

eDSMB® GxP Quality and Compliance

Your Guide to GxP Compliance and Management of Data Safety Monitoring Boards

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).

Certified ISO-IEC 27001 Systems, Services and Data Processing

The DSMB software and the associated services 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. Ethical's parent company GM Servizi is yearly audited by an authorized ISO 27001Certification Authority

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Integrated Validation Documentation and Support

eDSMB® ’s software, systems, and services for Data Safety Monitoring Boards comply with all regulations that apply to EA: GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11.
Ethical provides, as an integrated component of our eDSMB® Services, the full GAMP 5 validation documentation package and support.

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GDPR - EU General Data Protection regulation Compliance

Ethical GmbH is committed to ensuring the security and protection of the personal information and to provide a compliant and consistent approach to data protection. We have a robust and effective data protection program in place which complies with European Union General Data Protection Regulation (EU-GDPR)

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Download Your DSMB-DMC Complete Handbook

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



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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

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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