Endpoint Adjudication is used in Clinical Trials, to add a higher level of certainty to Endpoints Assessments by overcoming the potential bias of local Investigators judgments.

The eAdjudication® software platform streamlines the endpoint adjudication process from faster start to earlier finish. Sponsors can have more confidence in the efficient adjudication process, quality data free from bias or human error, with real-time results accessible to all authorized parties to expedite critical decisions. HOW WE HELP

Endpoint Adjudication - CEC Adjudication: Standard Definitions, Procedures and Software Tools to effectively manage Endpoint Adjudication Committees

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.

2020年11月17日 · 4 Phases of a Clinical Endpoint Adjudication Process. The clinical adjudication process is decided and piloted by the clinical team but needs input and help from several other teams such as operations, data management and IT. Once the decision is made to adjudicate one or more clinical endpoints, the process can begin. Phase 1: Study Preparation

The intuitive and user-friendly eAdjudication ® software connects the key adjudication stakeholders and helps manage smoothly and efficiently all types of adjudication operations, supporting data manageability, quality and security, enhancing communication, streamlining workflow, and simplifying process governance.

Endpoint Adjudication (EA) is the procedure by which clinical events identified as potential endpoints are submitted to a panel of independent experts to be assessed in a blinded way. EA provides an independent assessment of endpoint that are …

The Endpoint Adjudication Charter should include a description of the Clinical Trial related to Adjudication, Study objectives (primary, secondary, exploratory) and the rationale for the Endpoints Assessments.

2022年3月8日 · Not all clinical studies, however, benefit from the endpoint adjudication procedure and the additional cost and burden must be carefully weighted against the advantages. Here are five example situations when submitting the data to a blinded independent panel of experts provides the best chance of a correct assessment and strong study results.

eAdjudication® is a comprehensive Managed Software Service built over a single-purpose enterprise technology platform that supports every operation related to endpoint adjudication committee (CEC) management, contributing to the process best practices, quality control, and the flexibility to adapt to any scenario.