Clinical
Adjudication,
Simplified.

SafeWare™

SafeWare™ is built for modern trials


Streamline clinical adjudication for CEC and DSMB committees. SafeWare™, secure, audit-ready, and built to

meet FDA standards and

speed up your trial.


— Clinical Adjudication, Simplified.

SafeWare™ is built for modern trials


Streamline clinical adjudication for CEC and DSMB committees. SafeWare™, secure, audit-ready, and built to

meet FDA standards and speed up your trial.


— Clinical Adjudication, Simplified.

SafeWare™

Core Capabilities

Structured Review Workflows

Purpose-built forms guide reviewers through eligibility, neurological status, protocol deviation, and safety event adjudication — with required fields and built-in logic to enforce consistency.

Secure Document & Imaging Access

Reviewers access subject dossiers, CRF pages, and radiographic images directly within the platform. Files are view-only, protecting data integrity throughout the review process.

Consensus & Tiebreak Routing

SafeWare automatically manages multi-reviewer consensus logic, including tiebreak routing and flagging items for full CEC or DSMB discussion — reducing coordination burden on study teams.

Real-Time Dashboards

Track review status, outstanding items, and adjudication metrics across your study at a glance. Dashboards are role-appropriate, ensuring the right people see the right information.

Audit-Ready by Design

Every review action is captured with reviewer identity and timestamp. Submitted records are locked, creating a clean, defensible audit trail for regulatory submissions.

Enterprise-Grade Security

Two-factor authentication, role-based access controls, and controlled file permissions keep your trial data protected throughout the adjudication lifecycle.

Structured Review Workflows

Purpose-built forms guide reviewers through eligibility, neurological status, protocol deviation, and safety event adjudication — with required fields and built-in logic to enforce consistency.

Secure Document & Imaging Access

Reviewers access subject dossiers, CRF pages, and radiographic images directly within the platform. Files are view-only, protecting data integrity throughout the review process.

Consensus & Tiebreak Routing

SafeWare automatically manages multi-reviewer consensus logic, including tiebreak routing and flagging items for full CEC or DSMB discussion — reducing coordination burden on study teams.

Real-Time Dashboards

Track review status, outstanding items, and adjudication metrics across your study at a glance. Dashboards are role-appropriate, ensuring the right people see the right information.

Audit-Ready by Design

Every review action is captured with reviewer identity and timestamp. Submitted records are locked, creating a clean, defensible audit trail for regulatory submissions.

Enterprise-Grade Security

Two-factor authentication, role-based access controls, and controlled file permissions keep your trial data protected throughout the adjudication lifecycle.

Structured Review Workflows

Purpose-built forms guide reviewers through eligibility, neurological status, protocol deviation, and safety event adjudication — with required fields and built-in logic to enforce consistency.

Secure Document & Imaging Access

Reviewers access subject dossiers, CRF pages, and radiographic images directly within the platform. Files are view-only, protecting data integrity throughout the review process.

Consensus & Tiebreak Routing

SafeWare automatically manages multi-reviewer consensus logic, including tiebreak routing and flagging items for full CEC or DSMB discussion — reducing coordination burden on study teams.

Real-Time Dashboards

Track review status, outstanding items, and adjudication metrics across your study at a glance. Dashboards are role-appropriate, ensuring the right people see the right information.

Audit-Ready by Design

Every review action is captured with reviewer identity and timestamp. Submitted records are locked, creating a clean, defensible audit trail for regulatory submissions.

Enterprise-Grade Security

Two-factor authentication, role-based access controls, and controlled file permissions keep your trial data protected throughout the adjudication lifecycle.

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Built for Adjudication

Built for Adjudication

A secure, purpose-built platform that guides CEC and DSMB members through every step of the adjudication process. From data review to final determination — with a complete, auditable record at every stage.

Safety data

Review adverse events, serious adverse events, and surgical site infections directly in the portal. Classify each event, reclassify as needed, and complete the adjudication with a full documentation trail.

Protocol deviations

Identify and adjudicate deviations against pre-specified criteria. The portal captures your determination and supporting rationale, building a defensible record for each decision.

Neurological data

Access baseline neurological assessments and outcome data compiled in subject dossiers alongside radiographic images — all linked directly within the portal for side-by-side review.

Subject eligibility

Evaluate inclusion and exclusion criteria requiring medical judgment. The portal enforces quorum rules, routes tiebreaker reviews automatically, and escalates to committee discussion when consensus is not reached.

Clinical Expert Input

Gather consensus from clinical experts on endpoint definitions, adjudication criteria, and clinical significance thresholds — turning expert judgment into structured, documentable evidence.

Study-Specific Build

A configurable portal built around your trial's specific endpoints, adjudication workflows, and CEC structure — secured with two-factor authentication and role-based permissions from day one.

SafeWare™ integrates clinical data, imaging files, and structured review forms. Reviewers have everything they need, and nothing they don't.

Clinical event adjudication is one of the most scrutinized elements of any regulatory submission.


SafeWare™ gives your CEC, DSMB, Sponsor team, and clinical operations staff a

single, secure platform

to manage the entire process.


From eligibility review through safety event adjudication, everything including the audit trail FDA expects.

Clinical Adjudication, Simplified.