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