Phoenix CTMS

Phoenix CTMS is a web-based Clinical Trial Management System (CTMS) designed to streamline and automate various aspects of clinical trial management. It is suitable for organizations of all sizes, ranging from small research institutions and academic centers to large pharmaceutical companies and contract research organizations (CROs). According to the vendor, Phoenix CTMS is used by clinical research professionals, pharmaceutical and biotechnology companies, CROs, academic research centers, and government and non-profit organizations involved in clinical research.

Key Features

User Management: Phoenix CTMS includes a user module that allows for the management of user accounts. Each user account can be linked to a person or organization and has customizable language, timezone, and UI theme settings. Users can modify their settings and passwords, and password policies can be adjusted.

REST API: Phoenix CTMS provides a comprehensive REST API that enables programmatic manipulation and retrieval of data items, process automation, system integration, and creation of streamlined user interfaces. The API covers CRUD operations for all primary entities, query editor operations, DMS operations for document storage and retrieval, and more.

Installation: Phoenix CTMS offers an automated installation procedure for setting up a local environment. It can be installed on a virtual machine using virtualization software such as Oracle VM VirtualBox or VMware Workstation/Player. The installation process takes approximately one hour and includes the option to generate demo data for testing purposes.

Subject Management: Phoenix CTMS provides tools for effectively managing subjects in clinical trials. It allows for the creation and tracking of subject profiles, including personal information, medical history, and study-specific data. Subject enrollment and randomization can be efficiently managed, and subject data can be easily accessed and updated.

Trial Management: Phoenix CTMS offers comprehensive trial management capabilities, enabling the setup and configuration of trials, including visit schedules, staff duties, and subject groups. Users can create and customize trial-specific forms, questionnaires, and eCRFs. The system supports subject selection and enrollment workflows, facilitating efficient trial management.

Document Management: Phoenix CTMS includes a document management system (DMS) for organizing and storing trial-related documents. Users can upload and retrieve documents in various file formats. Documents can be associated with specific trial entities, such as subjects, visits, or inventory items, ensuring effective document organization.

Query Management: Phoenix CTMS provides a query management feature for creating, tracking, and resolving queries related to eCRFs. Study monitors or data entry clerks can raise queries, and notifications are sent to relevant team members. Queries can be categorized, assigned, and closed once resolved, ensuring efficient query management.

Data Export: Phoenix CTMS offers various export formats for eCRF data, including CSV, XLSX, PDF, and SQLite. Users can export specific data sets in their desired format for further analysis, reporting, or integration with other systems, providing flexibility in data utilization.

Audit Trail: Phoenix CTMS maintains a comprehensive audit trail of all modifications made to eCRFs and other trial-related data. The audit trail includes user information, timestamps, and record versions for each modification, ensuring data integrity and providing a transparent history of changes made to the trial data.

Electronic Signature: Phoenix CTMS supports electronic signatures for eCRFs. When an eCRF is switched to a verified state, principal investigators receive a notification and can sign the eCRF using their password for identity confirmation. Signed eCRFs are securely sealed and can only be unlocked by the investigator for necessary corrections.