Clinical Endpoint Adjudication
A secure, validated platform for independent clinical endpoint review by blinded expert committees. Ensure consistent, unbiased event classification across your clinical programme with structured voting workflows, automated case assembly, and full regulatory traceability from first event through final adjudication and database lock.
Secure, Validated Endpoint Adjudication
MTK's Clinical Endpoint Adjudication platform provides a purpose-built, fully validated system for managing the end-to-end adjudication lifecycle. From committee onboarding and case dossier assembly through independent voting, consensus resolution, and final classification, every step is conducted within a controlled, audit-trailed environment designed to meet the highest regulatory standards.
Whether your study requires cardiovascular MACE adjudication, oncology tumour response review, or multi-endpoint committee oversight, our platform adapts to your protocol complexity. Integrated with MTK's EDC, rSDV, DocuVault, and Analytics modules, the adjudication system ensures seamless data flow, eliminates manual case packaging, and delivers real-time visibility into committee performance and endpoint classification outcomes.
Comprehensive Adjudication Workflow
Our adjudication platform delivers a complete feature set for managing clinical endpoint committees, from case preparation and blinded review through voting, consensus, and real-time analytics -- all within a single validated environment.
Committee Management
End-to-end management of Clinical Event Committees (CEC) with structured workflows for every stage of committee operations and oversight.
- CEC member onboarding & credentialing
- Role-based training tracking & certification
- Intelligent workload balancing
- Conflict-of-interest management
Case Dossier Assembly
Automated assembly of comprehensive adjudication case packages, reducing manual effort and ensuring adjudicators receive complete, de-identified data.
- Automated case package assembly from EDC
- Source document & imaging integration
- Patient-level de-identification
- Configurable dossier templates
Voting & Consensus Workflows
Configurable voting models that support independent review, majority-rules decisions, and consensus-driven adjudication with structured tie-breaking.
- Independent blinded review
- Majority-rules voting models
- Consensus-driven adjudication
- Structured tie-breaking & escalation
Blinding Integrity
Robust blinding controls ensuring adjudicators review only de-identified, treatment-blinded data throughout the entire adjudication process.
- Treatment-blinded data presentation
- De-identified patient records
- Controlled unblinding procedures
- Blinding integrity monitoring
Full Audit Trail
Complete, 21 CFR Part 11 compliant audit trail that documents every decision, vote, classification change, and system action for regulatory traceability.
- 21 CFR Part 11 compliant trail
- Every vote & decision recorded
- Classification change tracking
- Electronic signatures with timestamps
Adjudication Analytics
Real-time dashboards providing visibility into event rates, adjudication timelines, inter-rater agreement, and overall committee performance.
- Event rate tracking & trend analysis
- Adjudication timeline monitoring
- Inter-rater agreement metrics (kappa)
- Committee performance dashboards
Multi-Therapeutic Adjudication Coverage
Our platform supports endpoint adjudication across a broad range of therapeutic areas, with configurable classification schemas and committee workflows tailored to each indication's regulatory and scientific requirements.
Cardiovascular
Comprehensive MACE adjudication with structured classification for cardiovascular death, myocardial infarction, stroke, and heart failure hospitalisation endpoints.
- MACE endpoint classification
- Stroke & TIA adjudication
- Myocardial infarction review
- Heart failure event assessment
Oncology
Independent tumour response assessment supporting RECIST, iRECIST, and custom criteria for progression, response, and survival endpoint adjudication.
- Tumour response assessment
- Disease progression review
- Survival endpoint classification
- RECIST / iRECIST criteria support
Neurology
Structured adjudication for cognitive and functional endpoints including neurological event classification and standardised assessment scoring.
- Cognitive endpoint assessment
- Functional assessment scoring
- Neurological event classification
- Standardised rating scales
Hepatic
Liver-related event adjudication with structured workflows for hepatotoxicity assessment, Hy's Law evaluation, and DILI classification.
- Liver-related event assessment
- Hy's Law evaluation
- DILI classification
- Hepatotoxicity grading
Built for Every Stakeholder
Our adjudication platform is designed to meet the distinct needs of sponsors, CROs, and adjudication committee members, delivering tailored workflows and interfaces that make every role more effective.
Sponsors
Gain confidence in your endpoint data with unbiased, independent classification and complete regulatory traceability across your clinical programme.
- Unbiased endpoint classification
- Regulatory-grade audit evidence
- Real-time committee oversight
- Cross-study adjudication visibility
CROs
Scale adjudication operations across multiple sponsors and studies with standardised workflows, reusable configurations, and rapid committee setup.
- Standardised adjudication workflows
- Multi-study committee management
- Rapid study setup & configuration
- Sponsor-level access partitioning
Adjudicators
Review cases efficiently with an intuitive interface designed for expert committee members, providing secure access to complete case dossiers on any schedule.
- Intuitive case review interface
- Flexible scheduling & availability
- Secure document access & viewing
- Mobile-friendly review capability
Connected Across the eClinical Suite
Our Adjudication platform is fully integrated with MTK's eClinical ecosystem. Bi-directional data flows, shared patient timelines, and a unified audit layer connect adjudication with EDC, rSDV, DocuVault, and Analytics -- eliminating manual case packaging and ensuring a single source of truth for endpoint data.
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EDC Integration
Automated event trigger notifications, real-time CRF data pull for case dossier assembly, and bi-directional adjudication outcome flow back to the clinical database.
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rSDV Integration
Direct access to verified source documents within adjudication case packages, linking CRA-verified data to endpoint review for enhanced data confidence.
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DocuVault eTMF Integration
Automated filing of adjudication charters, committee meeting minutes, training records, and final adjudication reports directly to the Trial Master File.
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eClinical Analytics Integration
Adjudication outcomes feed directly into cross-platform analytics dashboards for unified endpoint reporting, event rate monitoring, and programme-level insights.
Why Choose MTK for Adjudication
Choosing the right adjudication partner means more than selecting software. It means partnering with a team that understands endpoint science, committee governance, and the regulatory expectations for independent clinical event review.
Endpoint Expertise
Built and supported by professionals with deep experience in clinical endpoint adjudication across cardiovascular, oncology, neurology, and hepatic programmes.
Unified Platform
Adjudication is part of an integrated eClinical suite with EDC, RTSM, ePRO, CTMS, DocuVault, eConsent, rSDV, and Analytics -- all sharing one data layer.
Regulatory Ready
21 CFR Part 11 compliant, GDPR-ready, and ICH-GCP E6(R2) aligned out of the box. Complete validation documentation available for sponsor and regulatory review.
24/7 Support
Dedicated support team available around the clock for active adjudication studies. From committee queries to system administration, our team is there when you need them.
See Adjudication in Action
Schedule a personalised demonstration to discover how MTK's Adjudication platform can streamline your clinical endpoint review, ensure unbiased event classification, and deliver regulatory-grade audit evidence from first event through final committee decision.