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Description

CIMS Global delivers advanced data science platforms and eClinical solutions that are set to transform the landscape of clinical trials by enhancing the quality, efficiency, and speed of processes like data acquisition, processing, analysis, monitoring, and regulatory submissions. Their offerings feature groundbreaking tools such as CRE, DDM, DMC-HUB, and eBinder, as well as a comprehensive eClinical Suite that facilitates data collection, analytics, and clinical functions throughout all phases of a trial. CRE serves as a multi-tenant, validated Statistical Computing Environment specifically designed for compliant analysis of clinical data, leveraging R, RShiny, and the RStudio IDE within a secure framework ready for audits that aligns with 21 CFR Part 11 and GxP regulations. DDM stands out as a patented Dynamic Data Monitoring platform that visualizes cumulative treatment effects on a trial radar screen while also forecasting the likelihood of a trial’s success or failure. Additionally, the integration of these innovative solutions positions CIMS Global at the forefront of clinical trial technology, ensuring that researchers can achieve optimal outcomes in their studies.

Description

In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

R Yes 
RStudio Yes 

Integrations

R No 
RStudio No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

CIMS Global

Founded

2004

Country

United States

Website

cims-global.com

Vendor Details

Company Name

OpenText

Founded

1991

Country

Canada

Website

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

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Data Science

Access Control No 
Advanced Modeling No 
Audit Logs No 
Data Discovery No 
Data Ingestion No 
Data Preparation No 
Data Visualization No 
Model Deployment No 
Reports No 

Electronic Data Capture

Audit Trail No 
CRF Tracking No 
Data Entry No 
Data Verification No 
Distributed Capture No 
Document Imaging No 
Document Indexing No 
Forms Management No 
Remote Capture No 
Study Management No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Alternatives

Alternatives

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MainEDC Reviews

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