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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 Clinion RTSM?

Clinion RTSM simplifies the management of clinical trial supplies and patient randomization through the use of Interactive Response Technologies (IWRS). The Inventory module seamlessly connects with the Randomization module of Clinion RTSM Software, enabling the execution of both straightforward and intricate randomization strategies tailored to protocol requirements. Recognized as one of the leading integrated EDC/RTSM platforms in the market, Clinion allows site users to manage randomization, drug allocation, returns, and reallocation without the need to log into multiple systems or concern themselves excessively with reconciliation. Our straightforward and cost-effective pricing structure helps reduce the overall expenses associated with RTSM ownership, ensuring that quality and functionality are maintained. By combining EDC and RTSM modules, you can enhance operational efficiency and maximize the benefits of your clinical trial management processes.

Media

Media

Integrations Supported

Integrations Supported

Clinion EDC

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Online Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Clinion

Date Founded

2000

Company Location

India

Company Website

www.clinion.com/randomisation-and-trial-supply-management-software/

Categories and Features

Clinical Trial Management

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

Categories and Features

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5.0 out of 5 stars