Clinical Trial Management System

CTMS consists of a number of modules, which can be used together, separately or with other modules on our platform. You may choose certain options now and increase your use of CTMS anytime in the future.

CRA Activity Management

• Site visit planning and scheduling
• Centralized calendar to view CRA workload
• Separate CRA cabinet
• Study role-based permissions
• Digital signature (optional)
• Automated notifications on report delays
• Any additional custom notifications can be set up
• Monitoring Visits reports, confirmation & follow-up letters can be generated on customers templates
• Monitor Visit Report generation according to the type of visit (PSV, SIV, IMV, COV)
• Assessment metrics creation and CRA performance assessment
• Source Data Verification
• Action Items tracking
• Protocol deviation tracking
• Subjects enrollment log
• Customizable questionnaire
• Full integration with TMF, EDC systems

Subject Tracking and Invoicing

• Create study and site budgets
• Invoice based on various triggers: visit, procedures, milestones, etc.
• Set up any payment rules with overhead percentage, cost and extra cost reductions
• Keep different site budget versions and invoice according to specific version
• Copy budget template to speed up trial set-up
• Export and report any data on invoicing into sites
• Plan enrollment and compare with the real picture
• Plan and schedule patients visits
• Track all patient related data
• Track non-visit related activities (PTC management)
• Track unscheduled visits and procedures
• Manage open queries resolution
• Get overall reports on ready to be invoiced, approved and paid activities
• Generate invoices on client-specific or ready-to-use templates
• Track invoices status
• Void or approve invoices online

Investigators & Sites Management

• Feasibility process
• Site team assignment
• Site performance
• Capturing and tracking of all site communication
• Centralized IRB/LEC submissions and approval tracking
• Documents tracking (contracts, site regulatory documents, licenses and certificates)
• Investigators information (contact information, CV, experience, studies, therapeutic areas)
• Sites information (address, accreditation certificates, study team, structure, studies)
• Hospitals and out-patient clinics (addresses, description, equipment, capacity)
• Vendor information (address, pricing, services)
• Regulatory Authorities information (address, contact person, key information)
• Reports