Quality Assurance Managers and Endpoint Adjudication

How the eAdjudication® "Quality by Design" Architecture eases your job

Ethical has designed and manages eAdjudication® processes according to global quality assurance and security standards. We have incorporated mechanisms to facilitate user validation of the system and we include a validation package and support in every offer we make. The eAdjudication® software system allows quick access to audit trails, full implementation of company-specific SOPs, and comes with an additional “mirror” environment where acceptance and change management testing can be executed throughout the study duration.

Addressing Quality Assurance Managers Challenges with Endpoint Adjudication Studies

Ethical and eAdjudication® software and services simply make it easier for the Quality Assurance Manager to oversee Compliance and Quality of the Adjudication and decision-making process. Our software design and services comply with all pertinent ISO/IEC 27001 - EU General Data Protection Regulation (GDPR) requirements and controls. Our SOPs and electronic Record handling related to Clinical Processes and Quality Systems comply with all the relevant FDA and EMEA regulations.

An Integrated Quality Management System You Can Have Confidence In

Ready for Audits and Supplier Qualification Processes

For 20 years Ethical Staff gained experience working with many Sponsors, AROs and CROs for some 300 global clinical trials. We were always successfully qualified as Data Management and Software Services Providers, following a variety of processes and auditing procedures. So now our SOPs, Certifications, Documentation and Expertise are ready and available to support Your Qualification in the faster and most effective way.

Integrated Validation Expertise, Documentation and Support

Ethical’s software, systems, and services 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.

Managed in an ISO/IEC 27001 - EU GDPR - Compliant Environment

Ethical’s software design and service provisioning are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 information security management system requirements and security controls. Data Privacy and Security is managed in compliance with the recent GDPR (EU General Data Protection Regulation).

Discover How eAdjudication® Simplifies Quality Assurance

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

Download Ethical eAdjudication for Endpoint Adjudication Dossier

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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

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

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