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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 Loftware Cloud Clinical Trials?

Loftware Cloud Clinical Trials offers a powerful, cloud-based platform to manage the complex labeling and booklet requirements of clinical trials. Designed to ensure regulatory compliance, the software supports label creation, approval workflows, and distribution across global trial sites. Loftware Cloud simplifies the process with customizable templates, automatic barcode generation, and real-time tracking. By centralizing and automating clinical labeling, it enhances efficiency, reduces errors, and ensures that clinical trials meet the highest industry standards for compliance.

Media

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Media

Integrations Supported

Oracle Cloud Infrastructure
SAP Cloud Platform
SAP Store

Integrations Supported

Oracle Cloud Infrastructure
SAP Cloud Platform
SAP Store

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

Loftware

Date Founded

1986

Company Location

United States

Company Website

www.loftware.com/products/labeling/loftware-cloud-clinical-trials

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

Label Printing

Automation
Barcode Support
Categorization
Design Tools
Hardware Integration
Multi-Language Support
Product Data Integration
Regulatory Compliance
Templates

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