CTMS

InfoEd Global's Clinical Trials Management System (CTMS) is designed to bring structure to the administration of human studies and clinical research. The system links trials to related protocols, grants, contracts, publications, conflict of interest information, and patents within a single, centrally accessible platform. It is intended for investigators, coordinators, and administrators involved in managing clinical trials across research institutions.

The CTMS is accessible from any internet-connected computer and consolidates trial information in one location to reduce administrative burdens and support collaboration among all research personnel involved in a study.

Features for Investigators and Coordinators

• Create new protocols in a small number of steps
• Record or link required approvals — including regulatory approvals and contracts — to support study startup and site activation
• Track participant enrollment and progress throughout the trial
• Manage and share critical study documents
• Review accumulating trial data and safety information
• Manage communication with research team members, monitors, participants, and other stakeholders
• Track and manage financial activity associated with the trial

Features for Administrators

• Report on clinical trials and related financial activity across multiple departments, investigators, trials, and participants
• Standardize processes across the research enterprise using electronic research administration tools
• Audit trials to verify compliance with regulatory and institutional requirements
• Configure role-based security to control access to sensitive trial and participant information
• Customize the trial environment to support institution-specific processes and facilitate compliance

Clinical Trial Design

• Build out trial arms, visits, cycles, procedures, and billable events that make up a protocol
• Code and track all details of the protocol
• Create electronic case report forms
• Manage trials across multiple locations using coordinating center tools

Accounting Administration

• Capture details of the sponsor's proposed budget and institutional costs of providing trial services
• Automatically generate transactions for completed milestones and participant visits
• Record payments and age receivables
• Build and send invoices using customizable templates

Recruitment and Participant Tracking

• Match participants to trials and conduct feasibility assessments
• Interface with the institution's EMR/EHR system to improve data accuracy and reduce duplicative data entry
• Track all aspects of recruitment, enrollment, and trial participation from initial contact through completion or withdrawal

Document Management

• Capture and manage all trial-related information, correspondence, and documentation in a virtual regulatory binder
• Share critical study documents with all members of the research team
• Version uploaded documents
• Store and manage documentation related to individual participants

Reporting and Monitoring

• Review and report on accumulating participant data
• Set up alerts and reminders
• Track site monitoring visits, audits, and routine compliance reviews along with their outcomes
• Report on recruitment, enrollment, and completion of trial activities

InfoEd's CTMS supports integration with institutional EMR/EHR systems and includes tools for managing multi-site trials through coordinating center functionality. The platform is designed to support compliance with regulatory and institutional requirements and can be configured to reflect institution-specific workflows.