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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 OpenText Clinical Trial Quality Management?

In the past few years, the Life Sciences industry has faced fines and settlements totaling almost $15 billion due to compliance issues, highlighting the critical need for companies to adhere to best practices in pharmaceuticals, medical devices, and biotechnology. Furthermore, the management of clinical trials significantly impacts the duration, scope, and financial investments necessary for the advancement of drugs and medical devices. By leveraging OpenTextâ„¢ Clinical Trial Quality Management System (ctQMS), organizations can ensure compliance, reduce record-keeping costs, and promote collaboration to implement best practices throughout the clinical trial process. This strategic methodology not only boosts operational efficiency but also plays a vital role in the successful development of products. Ultimately, embracing such advanced systems can lead to more innovative solutions in the healthcare landscape.

Media

Media

No images available

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

OpenText

Date Founded

1991

Company Location

Canada

Company Website

www.opentext.com/info/clinical-trial-management

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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