Ethical’s software and business processes are built to meet globally recognized industry standards and regulatory requirements. These include the ISO/IEC 27001 for Information Security Management (ISMS), Good Clinical Practice (GCP), US FDA 21 CFR Part 11, EU GMP Vol. 4 Annex 11, the EU General Data Protection Regulation (GDPR), and GAMP 5 Documentation.
Ethical software design 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.
Ethical’s software, systems, and services for Clinical Committee Management 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 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)
eAdjudication
software solution
service description
Request your FREE copy of the Adjudication Charter Guide built by Ethical after reviewing more than 20 study charters. Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats.
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Here are some instructions on writing the right SOPs for DSMB operations.
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The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.
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