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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 OpenText™ 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.

What is Chronicles CTMS?

A comprehensive solution designed for Research and Development teams within the pharmaceutical sector, this product features an Electronic Trial Master File and Trial Management system. Additionally, it incorporates Electronic Document Management with support for eSignatures, ensuring compliance with the stringent 21CFR Part 11 regulations. This makes it an ideal choice for organizations operating in highly regulated environments, enhancing efficiency and compliance in clinical trials.

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Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub

Training Options

Not specified

Company Facts

Organization Name

OpenText

Date Founded

1991

Company Location

Canada

Company Website

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

Company Facts

Organization Name

Chronicles Research Team

Company Location

United States

Company Website

inchronicles.com

Categories and Features

Life Sciences

Not specified

Categories and Features

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