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What is Protocol Manager (CTMS)?

The Protocol Manager plays a crucial role in clinical operations by managing global trials across different phases of drug, device, biologic, and vaccine development. It establishes essential Standard Operating Procedures (SOPs) to ensure adherence to FDA's 21 CFR part 11 regulations. Utilizing Web Services technology, the platform enables seamless and automatic integration with a variety of popular EDC and IVRS solutions. For systems that do not support Web Services, an export/import feature is provided to facilitate integration. This all-encompassing tool includes a robust tracking system and database, enabling effective management of diverse trial information and metrics, which significantly boosts operational efficiency. Furthermore, it allows organizations to uphold stringent oversight throughout the trial process, safeguarding data integrity and ensuring compliance at each phase. As a result, the Protocol Manager not only streamlines operations but also supports the successful execution of clinical trials by promoting transparency and accountability.

What is Phoenix CTMS?

Phoenix CTMS is an advanced, integrated web application that merges the essential tools of clinical research—Patient Recruitment System (PRS), Clinical Trial Management System (CTMS), and Clinical Data Management System (CDMS)—into a unified, modular platform available for free under an open source license (LGPL 2.1). It is tailored to support the operational workflows and regulatory compliance requirements of academic research centers, contract research organizations (CROs), and hospitals conducting clinical trials across all phases. Developed through years of collaboration with the Medical University of Graz, Phoenix CTMS offers a secure and private encrypted subject registry that protects personally identifiable information (PII) and complies with stringent EU-GDPR standards. The system provides a powerful electronic data capture (EDC) package with unlimited JavaScript scripting on both server and client sides, supporting complex and large electronic case report forms (eCRFs) not easily handled by other solutions. Phoenix CTMS facilitates the management of multiple concurrent clinical trials while efficiently organizing site staff and resources. The platform enables users to formulate complex ad-hoc database queries and supports set operations to identify suitable subject candidates. Its turnkey design allows institutions to deploy the system quickly without integrating several separate applications, enhancing efficiency and data security. This system is ideal for organizations needing a serious open source alternative for clinical data management and trial execution. Phoenix CTMS also helps ensure compliance with ICH GCP (Good Clinical Practice) guidelines, providing a reliable and comprehensive research management tool. Overall, Phoenix CTMS combines flexibility, security, and comprehensive functionality to meet the evolving needs of clinical research professionals.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version

Pricing Information

$1 one-time payment
Free Version

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Phoenix CTMS

Company Location

Austria

Company Website

www.phoenixctms.org

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
HIPAA Compliant
Monitoring
Patient Database
Scheduling
Study Planning

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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