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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 OpenTextâ„¢ 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 MainEDC?

Advanced eClinical Solutions for EDC/ERT/eCOA markedly accelerates the initiation and conclusion of clinical trials by as much as five days, slashes costs related to monitoring by nearly 80%, and enhances both capitalization and appeal, with 89% of clients acknowledging its benefits. A remarkable 96% of data science professionals affirm that it fosters growth and innovation within the fields of Data Management and Data Science. Furthermore, 94% of researchers appreciate the user-friendly nature of the interfaces. Additionally, a robust internal expertise in Data Management 365 is a crucial component of our Data Management 365 strategy, enabling us to not only gain deeper insights into the hurdles encountered by Data Managers but also to refine MainEDCâ„¢ and share valuable technology and best practices with our clients effectively. This commitment to excellence ensures that we remain at the forefront of the industry while supporting our clients' success.

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Integrations Supported

Flex Databases

Integrations Supported

Flex Databases

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$399.00/month
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

Data Management 365

Date Founded

2015

Company Location

United States

Company Website

datamanagement365.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

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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Medidata Reviews & Ratings

Medidata

Dassault Systèmes