Endpoint Adjudication Regulatory

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

FDA Guidance for Industry
ABSTRACT:] "This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) [...]"

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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ABSTRACT: This guidance finalizes the draft guidance On the Establishment and Operation of Clinical Trial Data Monitoring Committees" November 2001 [...]

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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 [...].

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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.

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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.

Request a Demo of the eAdjudication® Software Solution

Download Ethical eAdjudication for Endpoint Adjudication Dossier

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An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

The objective of this paper, published on Therapeutic Innovation and Regulatory Science  was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the EU / USA in 2013 and 2014.

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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.

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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.

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