IRB, Ethics & Regulatory Compliance
RegX IRB, Ethics & Regulatory Compliance helps clinical, regulatory, and compliance teams manage IRB submissions, ethics committee coordination, approvals, renewals, amendments, consent documentation, site compliance, electronic approvals, and audit-ready regulatory records.
From Scattered Study Compliance Tracking to Controlled IRB and Ethics Management
Clinical studies require continuous coordination across IRBs, ethics committees, investigators, clinical operations, regulatory teams, and quality groups. RegX replaces manual tracking, email follow-ups, handwritten approvals, disconnected documents, and spreadsheet-based compliance monitoring with a structured platform for study approvals, eSignatures, documentation workflows, and inspection readiness.
Manual IRB Tracking
Manage submissions, approvals, renewals, amendments, and ethics committee communication in one place.
Approval Delays
Use electronic approval workflows to reduce manual signature delays and improve review accountability.
Limited Study Compliance Visibility
Track protocol compliance, consent status, regulatory documents, investigator files, and site readiness.
Inspection Readiness Gaps
Maintain documentation, version history, approval records, audit trails, and searchable study evidence.
Everything Clinical Compliance Teams Need to Manage IRB, Ethics, Approvals, and Study Compliance
IRB & Ethics Management
Manage IRB submissions, ethics committee coordination, approvals, renewals, and amendments.
- IRB Submission Management
- Ethics Committee Coordination
- Approval Tracking
- Renewal Management
- Amendment Management
Workflow & Collaboration
Coordinate submissions, reviews, approvals, notifications, escalations, and audit trails across clinical teams.
- Submission Workflows
- Review Coordination
- Approval Tracking
- Notifications & Escalations
- Audit Trails
Inspection Readiness
Support compliance monitoring, audit preparation, governance controls, and inspection support.
- Compliance Monitoring
- Audit Support
- Inspection Preparation
- Governance Controls
- Reporting & Analytics
Governance & Oversight
Provide leadership visibility into open approvals, renewals, compliance gaps, documentation status, and site readiness.
- Approval Dashboards
- Renewal Alerts
- Compliance Status Tracking
- Risk Visibility
- Executive Reporting
Study Compliance
Monitor protocol compliance, consent documentation, investigator files, regulatory records, and site compliance.
- Protocol Compliance Tracking
- Consent Management
- Regulatory Documentation
- Investigator Documentation
- Site Compliance Monitoring
eSignatures & Approval Control
Support secure, traceable electronic approvals across IRB submissions, ethics reviews, renewals, amendments, consent documents, and study compliance activities. Electronic signatures help replace handwritten approvals with controlled digital sign-offs while supporting requirements such as 21 CFR Part 11, ICH E6(R3), and applicable regional regulations.
- IRB eSignature Workflows
- Secure Electronic Approvals
- Signature Reason & Timestamp Capture
- Reviewer Identity Verification
- Approval History & Audit Trails
- Document-Level Sign-Off Tracking
Regulatory Documentation
Centralize study documentation with version management, traceability, search, and knowledge management.
- Study Documentation Repository
- Version Management
- Traceability
- Search & Retrieval
- Knowledge Management
From Study Submission to Signed, Inspection-Ready Compliance
Prepare
Collect study documents, investigator files, consent materials, protocol details, and required regulatory records.
Submit
Create and manage IRB or ethics committee submissions with required documentation and tracking details.
Review
Coordinate review activities, respond to questions, manage comments, and track approval progress.
Sign
Capture secure electronic signatures with signer identity, timestamp, approval reason, and document-level traceability.
Monitor
Track protocol compliance, consent status, investigator documentation, site compliance, and renewal timelines.
Inspect
Maintain audit trails, approval evidence, compliance reports, and searchable study documentation.
Stronger Control Across IRB, Ethics, Approvals, and Study Compliance Operations
Faster Approval Tracking
Manage submissions, renewals, amendments, approval status, and signature completion in one controlled workspace.
Secure Electronic Sign-Offs
Replace manual signature handling with traceable electronic approvals and complete approval history.
Better Study Compliance Visibility
Track protocol, consent, investigator, regulatory, and site documentation across studies.
Improved Collaboration
Connect IRB coordinators, clinical operations, investigators, regulatory affairs, compliance, and quality teams.
Reduced Compliance Risk
Identify missing documents, overdue approvals, unsigned records, renewal gaps, and site compliance issues early.
Stronger Documentation Control
Maintain version history, traceability, search, retrieval, signature records, and study knowledge management.
Inspection Readiness
Preserve audit trails, approval evidence, compliance monitoring records, and inspection-ready reports.
Built for Clinical Operations, IRB, Compliance, Regulatory, and Quality Teams
Executive Leadership
Monitor study compliance, approval risks, inspection readiness, and portfolio-level regulatory status.
Head of Clinical Operations
Oversee study approvals, site readiness, documentation status, and compliance performance.
Compliance & Regulatory Leadership
Track compliance risks, governance controls, audit readiness, approval status, and regulatory documentation.
IRB Managers
Manage IRB submissions, approvals, renewals, amendments, ethics committee coordination, and sign-off status.
Compliance Managers
Monitor protocol compliance, consent status, audit trails, documentation gaps, and inspection preparation.
Clinical Operations Managers
Coordinate study start-up activities, site compliance, approval timelines, and operational readiness.
IRB Coordinators & Study Start-Up Specialists
Prepare submissions, manage documentation, track approvals, coordinate follow-ups, and monitor signature completion.
Investigators, Regulatory Affairs & Quality Teams
Support study documentation, compliance reviews, electronic approvals, regulatory records, quality checks, and audit readiness.
Strengthen IRB, Ethics & Regulatory Compliance with RegX
Manage IRB submissions, ethics approvals, study compliance, eSignatures, documentation workflows, site readiness, and inspection evidence in one connected regulatory platform.