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CTMS · LMS · eTMF · QMS

One platform.Connecting studies, sites, teams & compliance.

The validated CTMS behind every study — people, documents, training, data and visits, under one inspection-ready roof.

100,000+

Active users

500+

Trials Managed

450+

Research Centres

The platform

Everything a trial needs.
One validated system.

Kronus unifies study and site management, eTMF, eISF, quality management, learning management and workflow automation — with real-time reporting throughout. Simplify operations, improve collaboration and keep every stage of the trial inspection-ready.

Unifies
Study ManagementSite ManagementeTMFeISFQuality ManagementLearning ManagementWorkflow Automation
Modules · See it in action

Modular by design.
One ecosystem.

Feature · 01

People

Centralise user management across your organisation. Manage internal and external users, roles, permissions, departments, and reporting structures while ensuring the right people have the right access at the right time.

Feature · 02

Document Management

The Kronus electronic Trial Master File (eTMF) provides a secure, centralised repository for managing essential clinical trial documentation throughout the study lifecycle. Aligned with FDA 21 CFR Part 11, EU Annex 11 and ICH-GCP, it keeps documentation inspection-ready while improving collaboration, visibility and compliance.

Key features
  • Centralised Document Repository: Securely store and organise all trial documentation using the TMF Reference Model or configurable folder structures.
  • Document Control: Version control, review and approval workflows, electronic signatures and comprehensive audit trails ensure document integrity.
  • Role-Based Access: Control document visibility and permissions based on user roles and responsibilities.
  • Workflow Automation: Streamline document reviews, approvals, notifications and milestone tracking with configurable workflows.
  • Real-Time Oversight: Monitor document completeness, TMF health, milestones and inspection readiness through interactive dashboards.
  • Regulatory Compliance: Maintain complete traceability and support global regulatory requirements with validated processes and secure record management.

The Kronus eTMF empowers study teams to manage clinical trial documentation with complete oversight, operational efficiency and inspection-ready compliance.

Feature · 03

Learning Management

The Kronus Learning Management System (LMS) is built for the rigorous training and compliance demands of the life sciences sector. Aligned with FDA 21 CFR Part 11, EU Annex 11 and ICH-GCP, it offers a secure, centralised platform for delivering, managing and tracking training across an organisation.

Key features
  • Centralised Training Content: Streamlined management of SOPs, policies and training material with robust version control and full document history.
  • Targeted Learning Delivery: Role-based training assignments with configurable mandatory and elective learning paths.
  • Flexible Training Methods: Supports both eLearning and facilitated training, with compatibility for SCORM, videos, PDFs and other multimedia formats.
  • Automation & Efficiency: Easy enrolment for recurring and refresher courses, with automated reminders for upcoming or overdue training.
  • Regulatory Readiness: Electronic signatures for acknowledgments, timestamped records and full audit trails ensure compliance.
  • Performance Tracking: Real-time tracking of learner progress, completions and assessments, with detailed reporting for audits and inspections.

The Kronus LMS keeps every team member trained, current and inspection-ready across the full clinical trial lifecycle.

Feature · 04

Master Data

A configurable master data platform for managing stakeholders, operational records and organisational assets — from Investigators, Participants, Sponsors, Vendors and Laboratories to Equipment Registers, Calibration Tracking, Quality Audits, Non-Compliances, CAPAs and Vendor Management.

The Kronus Database module provides a centralised foundation for compliant clinical research operations and tracking activities.

Feature · 05

eCV Builder

The Kronus electronic Curriculum Vitae (eCV) module provides a secure, centralised solution for managing staff qualifications, experience and credentials. It simplifies CV maintenance and regulatory compliance, keeping personnel records accurate and up to date while reducing administrative effort.

Key features
  • Centralised eCV Repository: Maintain a single, secure source of truth for staff CVs.
  • Profile Management: Capture qualifications, certifications, education, employment history, therapeutic expertise and research experience.
  • Document Version Control: Track CV revisions, approvals and historical versions with complete audit trails.
  • Workflow Automation: Manage CV reviews, approvals, updates and expiry reminders.
  • Compliance & Reporting: Support inspection readiness with electronic signatures, timestamped records and comprehensive reporting.

The Kronus eCV module keeps staff credentials accurate, compliant and readily accessible throughout the clinical trial lifecycle.

Feature · 06

Visit Scheduler

The Kronus Visit Scheduler simplifies the planning, scheduling and tracking of participant visits throughout the clinical trial lifecycle.

Key features
  • Protocol-Driven Scheduling: Automatically generate participant visit schedules based on study protocols and configurable visit windows.
  • Participant Management: Track participant enrolment, visit status and progress from a centralised dashboard.
  • Compliance Monitoring: Monitor visit adherence and missed visits.
  • Real-Time Visibility: Gain complete oversight of participant activity and visit tracking across studies.

The Kronus Visit Scheduler helps research teams manage participant visits efficiently and maintain protocol compliance at every stage.

Capabilities

Built deep.
Configured fast.

Role-Based Access & Permissions
Electronic Signatures & Comprehensive Audit Trails
FDA 21 CFR Part 11, EU Annex 11 & ICH-GCP Compliance
GDPR & POPIA Data Privacy Compliance
Dynamic Forms & No-Code Configuration
Workflow Automation & Configurable Processes
Task Management & Activity Tracking
Automated Notifications & Reminders
Real-Time Dashboards & Analytics
Multi-Study & Cross-Site Collaboration
Centralised Document Management
Centralised Master Data Management
Single Sign-On (SSO) Integration
Built for
Contract Research Organisations (CROs)Research SitesLaboratoriesSponsorsQuality & Regulatory TeamsAcademic & Research Institutions
Compliant with
FDA 21 CFR Part 11EU Annex 11ICH-GCPHIPAAGDPRPAIA

See Kronus in a
30-minute working session.