EAC Services

Endpoint Adjudication Committee (EAC)

Tailored EAC services designed to meet the unique needs of your study

Clinical studies in specialized therapeutic areas require the right expertise to ensure accurate, consistent evaluation of trial data. Advarra provides expert adjudicators with the clinical expertise necessary to assess various outcomes—whether protocol-defined endpoints or subjective clinical events. No matter the specialty or study location, Advarra delivers high-quality adjudication to support reliable trial results.

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EAC Info Sheet

Independent Endpoint Adjudication for All Types of Studies

Regardless of the therapeutic area, study design, geographic region, or other unique study considerations, our experienced team and adaptable processes can navigate any level of trial or endpoint complexity — ensuring reliable and consistent study outcomes.

Unmatched Expertise Across All Therapeutic Areas

Advarra’s 1500+ member network of experts includes clinicians and key opinion leaders capable of evaluating even the most complex endpoints across all specialties, including those involving subjective assessments and intricate disease courses.

Fast Committee Formation and Adjudication Outcomes

Thanks to our extensive expert network, committees can be formed in 5 weeks and ready to adjudicate events in ~6 weeks after adjudication planning. Once the charter and adjudication forms are defined, the customized adjudication platform supports timely adjudication reviews.

Advanced Technologies for Data Security and Integrity

Advarra’s Safety Oversight Administration and Reporting (SOAR™) platform ensures adjudication assessments are properly documented, auditable, and accessible by relevant stakeholders through role-based access within a secure environment.

Comprehensive EAC Services

EAC Setup and Charter Development

Member Identification: Advarra will identify potential members who have the required expertise for sponsor approval and manage qualification and contracts for the selected members.
Charter Development: Advarra will collaborate with the clinical team and then committee members to develop a charter that includes adjudication workflows, adjudication form with definitions and potential actions, dossier components, consensus outcome requirements, meeting plans, and other required elements.
Rapid Start-up: Advarra achieves the industry’s fastest average EAC formation time of ~5 weeks, thanks to our 1500+ member expert network and existing relationships with top research institutions. Once adjudication planning is complete, committees can begin adjudicating in ~6 weeks.

Excellence in EAC Execution

Collaborative Project Management: Your EAC project manager acts as a single point of contact to streamline communication between the Advarra EAC team, committee members, sponsor, sites, and CRO trial team to provide ongoing support throughout the duration of the trial.
Comprehensive Meeting Facilitation: Your EAC project manager will schedule and facilitate all committee meetings, including organizational kickoff, ad hoc meetings, and non-consensus meetings, where all EAC members collectively review cases and make final event determinations.
Flexible Event Management: Advarra will actively manage each event through the adjudication process, respond to adjudicator queries, and provide final outcome assessments while maintaining the confidentiality of each reviewer’s rationale. Advarra can also work with sites and sponsors to obtain source documents and data in a timely manner to support the overall adjudication process.
Rapid Adjudication Turnaround: Adjudication decisions are documented within SOAR and then delivered to the sponsor using a mutually agreed communication process.
Streamlined Communications Across Review Committees: While the review committees are separate, your EAC project manager can align adjudication activities with the Data Monitoring Committee (DMC) activities to ensure recently adjudicated data is included in DMC data reviews.

Safety, Security, Integrity

Secure Data Exchange Management: Advarra’s Safety Oversight Administration and Reporting (SOARTM) Platform securely houses all EAC data for adjudicator review and documentation of committee assessments for individual cases.
Unbiased and Independent: Advarra maintains complete independence from trial sponsors and CROs, effectively eliminating any potential bias within committee operations. This commitment is upheld through a rigorous member selection and qualification process, along with carefully managed meeting facilitation. These measures collectively uphold the highest standards of integrity in adjudication outcomes.

Advarra’s SOAR™ Platform Maximizes Data Safety and Integrity

The Safety Oversight Administration and Reporting (SOARTM) Platform from Advarra is a secure technology environment that can store study data, provide role-based access for committee members, and help ensure inspection readiness for all EAC data and operations. SOAR enables:

Startup and Adjudication Efficiency

Get up running quickly by using pre-configured workflows, or
Incorporate custom workflows to accommodate specialized protocol requirements
Perform initial dossier redaction with AI-enabled tools
Automate query handling

Compliance

Stay compliant with all applicable international privacy regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11Stay compliant with all applicable international privacy regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11
Track access to EAC documents and outcomes for all authorized users within SOAR, including sponsors, sites, study teams, and committee members
System is audit-ready at all times

Flexibility and Transparency

Integrate with other study technologies, including Electronic Data Capture (EDC) systems, enabling efficient data exchange
Support various adjudication workflows, such as parallel, sequential, and full panel reviews, among others
Use an integrated DICOM image reader

Featured Content

Blog

A Look at the Processes Behind Clinical Endpoint and Event Adjudication

See how Advarra’s tech-enabled adjudication platform leverages expert collaboration and secure data integration to streamline clinical endpoint evaluation.

Blog

DMC vs EAC: What’s the Difference?

Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.

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Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

How do you know your experimental therapy is working? Sometimes, it can be as simple to determine as comparing drug

Info Sheet

Endpoint Adjudication Committee (EAC) Services Info Sheet

Secure independent evaluation and adjudication of complex clinical trial endpoints.

Frequently Asked Questions

Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.

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