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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

The software Ethical design and the provided 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

Integrated Validation Documentation and Support

Ethical’s software, systems, and services for Endpoint Adjudication 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 eAdjudication® Services, the full GAMP 5 validation documentation package and support.

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 FRE 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

Request a Demo of the eAdjudication® Software Solution

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