Highly rated by customers | 4.2 / 5 stars

Clinical Trial Management Software (CTMS)

ResearchManager CTMS brings structure to every phase of clinical research by integrating site management, monitoring, budgeting, project management, and team communication into a single secure, organized, and customizable environment. This ensures effective collaboration among all stakeholders toward the successful completion of the study.

  • Up to 25% faster completion of studies
  • Up to 30% lower operating costs
  • Up to 40% more efficient workflows between teams and sites

Built for compliant clinical research

ISO27001-1-1
gdpr
NHS-1
fda-21-cfr-part-11-1-1
ich
HIPPA-Compliance-1
GAMP-logo-png

A flexible CTMS that integrates with existing workflows

CTMS solutions that force users to work within fixed structures that don’t align with their own processes actually create more work instead of less. ResearchManager CTMS is fully configurable. You decide which components you want to use, and our consultants set up the workflows based on how your organization already operates.

  • Customizable forms and fields.
  • Flexible structure based on the type of program or stage of study.
  • Choose from preset templates.

Clarity and Structure Through Parallel Processes

Operational processes in clinical research rarely proceed in a linear fashion; instead, they often run in parallel. In the CTMS, main and sub-processes can be created flexibly, each with its own status. This provides a clear overview of the progress of each component and allows for control over the entire study.

Real-time overview and team coordination

Whether the CTMS is used for local study management or for central coordination across multiple sites and studies, ResearchManager CTMS supports both from a single platform.

Processes

  • Study and Site Management: Manage study data, participating sites, site visits, site feasibility, and performance from a single, centralized overview.
  • Budget and Contract Management: Keep track of study budgets, income, and expenses; prepare quotes; and follow up on outstanding invoices.
  • Amendment Management: Record changes to the approved study design in a structured manner.
  • Project Management: Stay on top of tasks and deadlines, and work purposefully toward academic milestones.
  • Monitoring: Prepare monitoring reports for each site and follow up on findings in a structured manner.
  • QMS and Incident Management: Ensure quality through SOPs, training, audits, and CAPA management.

These are example processes. The CTMS can be configured to make existing workflows more efficient.

Features

  • Subject enrollment: Get real-time insight into screened, enrolled, and withdrawn participants through integration with EDC.
  • Cross-stakeholder communication: Streamline communication between stakeholders through queries for PIs and researchers, supported by automated notifications.
  • Reports and audit trails: Export reports in your organization’s branding with a single click.
  • Dashboards and notifications: visual insight into inclusions, deadlines, pending actions, and academic performance for faster decision-making.

Scalability: from a single study to hundreds running simultaneously

Whether you’re managing one study or hundreds at the same time, the CTMS scales with your organization. You’ll always have a centralized overview of all ongoing studies and submissions, each with its own workflow that can be customized entirely to your needs.

CTMS as Momentum Leader

ResearchManager CTMS/eTMF has been recognized by users as a Momentum Leader on G2, a fast-growing and highly acclaimed solution within clinical research.

Key Features

Configurable study and site management
Configurable study and site management

  • Support for phase I-IV, device- and investigator-initiated studies
  • Fully configurable study design per protocol
  • Flexible workflows by study and site
  • Central registration of studies, sites and departments involved
  • Managing milestones, schedule and critical deadlines
  • Automated notifications and email notifications

Complete monitoring and financial control
Complete monitoring and financial control

  • Real-time insight into study progress and inclusions
  • Monitoring per site with recording of performance
  • Management of protocol amendments and follow-up
  • Advanced reporting module and reporting engine
  • Dashboards with real-time KPI overview
  • Budget management by participant, department and site
  • QA recording of deviations, issues and CAPAs with full traceability

Security & Integrations
Security & Integrations

  • REST API
  • Single Sign-On (SSO)
  • Role-based permissions
  • Electronic signatures
  • Two-factor authentication

Hans Middelweerd

Hans Middelweerd

Global Sales Manager - Academic & Non-Profit

Thierry Wetting

Thierry Wetting

Global Sales Manager - CROs & Sponsors

Bring more clarity, control, and peace of mind to your clinical trials