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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 Clindex?

Discover a holistic and cohesive approach with our Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), and Electronic Data Capture System (EDC) seamlessly integrated. Our versatile Clinical Trial Software System makes it simple for you to access all your research data effortlessly. You can opt to run Clindex® on your own infrastructure or take advantage of the Fortress Medical Cloud (SaaS – Software as a Service) for added convenience. With global cloud capabilities, your information is safely stored in a SOC 3 certified data center, providing peace of mind. Whether you wish to build your own study database or need support, Clindex® provides all the essential tools you need. Our user-friendly quick start manuals, along with extensive help documentation, guide you thoroughly through the setup process. If you prefer a more tailored approach, our dedicated Clindex services team is available to create a study customized to your specifications, ensuring a seamless and efficient experience. Additionally, the flexibility of our system allows for ongoing improvements and updates, keeping your research at the forefront of technological advancements.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Fortress Medical Systems

Date Founded

1997

Company Location

United States

Company Website

www.fortressmedical.com

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

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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