Clinical Trial Management System

The Clinical Trial Management System (CTMS) by Cloudbyz is an integrated solution built on the Salesforce cloud platform, designed to streamline clinical trial operations. It provides comprehensive management of trial processes with real-time visibility and analytics, covering study planning, budgeting, startup, management, and closeout phases.

Project and Study Management: This system facilitates end-to-end project management for clinical trials. Users can set up and visualize studies according to protocol requirements, accessing details such as phase, type, therapeutic area, and more. It also allows for tracking of ethical and regulatory approvals, managing study teams, and organizing content by approval and expiry dates.

Site Management: Engage with sites directly, assign them to studies, and track documentation, credentialing, and activation status. The system provides an investigator portal for delivering content and services to clinical research sites.

Site Feasibility: Create and customize study feasibility templates, send surveys, and record responses in real-time. Evaluate responses using dashboards and reports, and save site credentials for future reference.

Subject Management: Gain real-time visibility into subjects and track visit activities and schedules, defining procedures and payment policies based on budgets and protocols.

Clinical Monitoring: Set up monitoring schedules, identify data discrepancies, and perform risk-based monitoring with key risk indicators. The system supports robust review processes and performance tracking with smart metrics and reports.

eTMF/eReg: The eTMF solution offers a cloud-based repository for clinical trial documents, enabling digital capture, management, and sharing. It ensures real-time visibility for stakeholders and includes features like pre-built templates and restricted file access.

Randomization & Trial Supply Management: This customizable solution handles randomization schemes and trial supply management tasks, such as inventory tracking and automated orders.

Budget Management: The system provides tools for budget estimation, planning, and payments management, with real-time tracking of expenses and budget projections. Users can set up study and site-level budgets and generate metrics for financial analysis.

Payments: Generate payments, create invoices, and manage budgets with template-based modules. The system simplifies accounting practices and allows for different payment frequencies per site.