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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

R
RStudio

Integrations Supported

R
RStudio

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

CIMS Global

Date Founded

2004

Company Location

United States

Company Website

cims-global.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

Data Science

Access Control
Advanced Modeling
Audit Logs
Data Discovery
Data Ingestion
Data Preparation
Data Visualization
Model Deployment
Reports

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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