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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 CIMS Global?

CIMS Global offers cutting-edge data science platforms and eClinical solutions aimed at revolutionizing the clinical trial landscape by improving the quality, efficiency, and speed of key processes such as data collection, analysis, monitoring, and regulatory submissions. Their suite of innovative tools includes CRE, DDM, DMC-HUB, and eBinder, along with a complete eClinical Suite designed to support data gathering, analytics, and clinical operations throughout every stage of a trial. Specifically, CRE functions as a multi-tenant, validated Statistical Computing Environment tailored for compliant clinical data analysis, utilizing R, RShiny, and the RStudio IDE within a secure audit-ready framework that complies with 21 CFR Part 11 and GxP regulations. DDM emerges as a patented Dynamic Data Monitoring platform that provides visual insights into cumulative treatment effects through a trial radar screen while also predicting the likelihood of trial success or failure. Moreover, the seamless integration of these advanced solutions not only reinforces CIMS Global's leading position in clinical trial technology but also empowers researchers to attain the best possible outcomes in their studies. This commitment to innovation ensures that every aspect of clinical trial management is streamlined and data-driven.

Media

No images available

Media

Integrations Supported

Integrations Supported

R
RStudio

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub

Company Facts

Organization Name

OpenText

Date Founded

1991

Company Location

Canada

Company Website

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

Company Facts

Organization Name

CIMS Global

Date Founded

2004

Company Location

United States

Company Website

cims-global.com

Categories and Features

Life Sciences

Not specified

Categories and Features

Data Science

Not specified

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