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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 Cytel?

Cytel is recognized as a leading global innovator in the realm of software dedicated to clinical trial design, biometrics, and sophisticated analytics, with a goal of enhancing clinical trial efficiency while empowering pharmaceutical firms to fully leverage both clinical and real-world data. Founded in 1987 by esteemed statisticians Cyrus Mehta and Nitin Patel, Cytel has maintained its position at the forefront of adaptive clinical trial technology and biostatistics. Its flagship software, the East Horizon platform, plays a crucial role in supporting accurate trial design and simulation, utilizing adaptive and Bayesian approaches to refine protocols and streamline the drug development journey. The East Horizon platform represents a holistic integration of Cytel's trusted software solutions, boasting R integration that markedly enhances trial design capabilities. Additionally, Cytel offers the Xact software suite, an extensive toolkit tailored for statistical analysis of smaller datasets, effectively addressing challenges posed by sparse and missing data. By persistently innovating and broadening its range of products, Cytel is dedicated to delivering state-of-the-art solutions that align with the dynamic demands of clinical research, ensuring that researchers have the tools necessary to improve patient outcomes. As a result, Cytel continues to shape the future of clinical trials through its unwavering commitment to excellence in software development and analytics.

Media

No images available

Media

Integrations Supported

R

Integrations Supported

R

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

OpenText

Date Founded

1991

Company Location

Canada

Company Website

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

Company Facts

Organization Name

Cytel

Date Founded

1987

Company Location

United States

Company Website

cytel.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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