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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

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.

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.

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 the Endpoint Adjudication Charter Template. By the "Endpoint Adjudication" Linkedin Group 

In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.

Adjudication Charter - Download the Endpoint Adjudication Charter Template designed by the Endpoint Adjudication Group on LinkedinREAD MORE

Endpoint Adjudication Committees: Uppsala Clinical Research UCR provides its Feedback on eAdjudication

Uppsala Clinical Research Center (UCR), a top Academic Research Organization based in Sweden, shares its experience in using eAdjudication platform to manage the central assessment of Clinical Trial Endpoints (CEC).

Endpoint Adjudication Committees: Uppsala Clinical Research UCR provides its Feedback on eAdjudicationREAD 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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