Clinical Endpoint Adjudication FDA / EMA Regulations

We Comply with the Regulations that Apply to Us. 
We Make Sure Your Submission Complies with the Ones that Apply to You.

Ethical’s software, systems and services comply with all regulations that apply to endpoint adjudication: GxP, GAMP 5 Validation, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, ISO 27001. From the adoption of your endpoint adjudication charter to your FDA and EMA submissions, we help you cover every step from the forming and staffing of adjudication regulatory to the creating and maintaining of audit trails.

Endpoint Adjudication: Improving Data Quality, Validating Trial Processes and Results, and Reducing Risks for Patient

Streamlined by the efficiencies of eAdjudication® software and services - and practiced by independent panels of experts following blinded standardized procedures - Endpoint Adjudication can improve the accuracy, efficiency and quality of assessments.

Endpoint Adjudication: Quality Data Management

Quality Data Management

Endpoint Adjudication: Validated Trial Outcomes

Validated Trial Outcomes

Endpoint Adjudication: Improved Patient Outcomes

Improved Patient Outcomes

Endpoint Adjudication Regulations and Guidelines

Here are helpful links to THE FDA and EMA guidance documents that address core concerns of endpoint adjudication: data monitoring committees, real-world evidence, imaging-based evidence, and the two therapeutic areas in which the regulatory agencies do require the use of endpoint adjudication: diabetes and oncology.

Establishment and Operation of Clinical Trial Data Monitoring (2006)

ABSTRACT: "This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) [...] that may carry out important aspects of clinical trial monitoring [...]"


Establishment and Operation of Clinical Trial Data Monitoring

NOTE: FDA released a new Guidance Draft - August 2017
ABSTRACT: This guidance finalizes the draft guidance On the Establishment and Operation of Clinical Trial Data Monitoring Committees" November 2001 [...]


Guideline on Data Monitoring Committees

EMA Committee for Medicinal products for human use (CHMP)
ABSTRACT: This Guideline document deals with independent Data Monitoring Committees. It is intended as an overview guide to highlight the key issues involved when sponsors include data monitoring committees as [...].


Real-World Evidence for Medical Devices

FDA Guidance for Industry
ABSTRACT: FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it is sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices.


eAdjudication® Software and Services Provide an Objective Basis for More Objective Results

The eAdjudication® software platform streamlines the overall Endpoint Adjudication process. It improves the accuracy of the data, reduces bias, provides immediate results - all of which lead to more timely decisions. Increasing the quality and integrity of the data reduces bias and patient risk - especially in multicenter studies with subjective or image-based endpoints. Establishing an endpoint map created through the charter template, as well as the real-time reporting of results, encourages thinking in a framework that may otherwise not occur without this process and software. Flagging data immediately enables quicker needed adjustments. Saving time, saving money and maybe even lives.

Download Your Endpoint Adjudication Handbook (36 pages)

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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

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