CTMS

ResearchManager CTMS is a clinical trial management system designed to support the full operational management of clinical studies. It centralises site management, budget control, progress monitoring, and documentation into a single integrated platform, providing real-time visibility across studies and sites. The tool is used by CROs, sponsors, universities, and healthcare institutions.

The platform has been in use by more than 200 organisations for over 13 years and is recognised as a Momentum Leader on G2. It is certified to ISO 27001 and NEN 7510, and compliant with GCP, GDPR, FDA 21 CFR Part 11, ICH-GCP, and HIPAA.

Study and Site Management

• Supports phase I–IV studies, device studies, and investigator-initiated studies
• Fully configurable study setup per protocol
• Flexible workflows configurable per study and per site
• Central registration of studies, sites, and involved departments
• Management of milestones, planning, and critical deadlines
• Automated notifications and email alerts

Monitoring and Financial Control

• Real-time insight into study progress and patient inclusions
• Per-site monitoring with performance tracking
• Management of protocol amendments and follow-up
• Advanced reporting module and reporting engine
• Dashboards with real-time KPI overviews
• Budget management per participant, department, and site
• QA registration of deviations, issues, and CAPAs with full traceability
• Contracts, budgets, milestones, and payments managed centrally per study and per site
• Automated workflows to reduce administrative actions and shorten turnaround times

Compliance, Security, and Integrations

• Role-based access controls
• Single Sign-On (SSO) support
• Two-factor authentication
• Validated electronic signatures
• Full audit trail of all actions
• Compliant with FDA 21 CFR Part 11 and ICH-GCP
• Secure data storage in accordance with ISO 27001, GDPR, and HIPAA
• Import and export capabilities in multiple formats
• REST API for reading and writing data

Platform Context

• CTMS is part of the broader ResearchManager Clinical Research Suite, which also includes EDC, RTSM, Visit Planning, Patient Recruitment, eConsent, ePRO, eTMF, and RIMS modules
• Professional services are available covering study management, regulatory support, data management, monitoring, and reporting
• The platform serves both academic and healthcare organisations as well as CROs and sponsors

ResearchManager CTMS is deployed as a validated, cloud-based platform with data storage conforming to ISO 27001, GDPR, and HIPAA requirements. It integrates with other modules in the Clinical Research Suite and supports external connectivity via REST API.