Clinical Trial Management System (CTMS)

Cloudbyz Clinical Trial Management System (CTMS) is a comprehensive, cloud-based solution built on the Salesforce platform, designed to manage and streamline clinical trial operations across all phases. It provides real-time visibility, centralized data access, and collaborative tools for sponsors, CROs, and research sites. The system supports planning, budgeting, site management, subject tracking, monitoring, and trial close-out, enabling faster, more efficient, and compliant clinical research execution.

Features

• Project and Study Management: Set up and manage studies with detailed protocol tracking, milestones, tasks, and team assignments.
• Site Management: Assign and monitor sites, manage documentation, credentialing, equipment, and activation status.
• Site Feasibility: Create and customize feasibility templates, send surveys, and evaluate responses with dashboards.
• Subject Management: Track subject visits, procedures, and payment policies in real time.
• Clinical Monitoring: Schedule and manage monitoring visits based on predefined plans.
• eTMF/eReg: Centralized document repository with regulatory tracking and compliance support.
• Randomization & Trial Supply Management: Manage drug supply logistics and randomization schemes.
• Budget Management: Define and track study and site budgets with templates and real-time analytics.
• Payments: Automate payment workflows including advance, milestone, and holdback payments.
• Patient Recruitment: Manage recruitment campaigns, pre-screening, and communication workflows.

Capabilities

• End-to-End Trial Oversight: Supports full lifecycle management from planning to close-out.
• Real-Time Data Access: Centralized dashboards and analytics for informed decision-making.
• Integrated Collaboration: Facilitates communication between sponsors, CROs, and sites.
• Regulatory Compliance: Built-in support for FDA 21 CFR Part 11, HIPAA, and global standards.
• Customizable Workflows: Configurable modules to adapt to specific organizational needs.
• Salesforce Native: Leverages Salesforce’s scalability, security, and low-code flexibility.
• Audit Trails and E-Signatures: Ensures traceability and compliance with regulatory requirements.

Benefits

• Accelerates trial setup and execution timelines.
• Improves operational efficiency and reduces manual effort.
• Enhances data accuracy and quality across trial phases.
• Enables proactive risk management and compliance tracking.
• Boosts collaboration and transparency among stakeholders.
• Reduces costs through automation and centralized control.
• Scales easily to support global, multi-phase studies.