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Home / GxP Compliance

Clinical Endpoint Adjudication GxP Quality and Compliance

eAdjudication® Solutions: Your Guide to Compliance and Oversight for All Endpoint Adjudication Phases and Outputs 

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

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.

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Integrated Validation Documentation and Support

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.

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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 Ethical's complete Endpoint Adjudication Charter Guide

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.

Event Adjudication Charter GuideREAD MORE

CEC Adjudication: Regulators, what do they think? #1: FDA

 In the vast majority of cases, the studies are intended for a regulatory submission seeking marketing authorization for our drugs. So, what do regulators think about CEC Endpoint adjudication?

CEC Adjudication: Regulators, what do they think? #1: FDAREAD MORE

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included? 

Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work.

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?READ MORE

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