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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 BSI CTMS?

BSI CTMS stands out with its cutting-edge interface and smart data visualization features. Our software for managing clinical trials goes beyond mere aesthetics, providing essential tools that support pharmaceutical, biotech, and diagnostics sponsors, as well as contract research organizations (CROs) and academic sites (SMOs), in efficiently overseeing their clinical trials. The ongoing development of BSI CTMS is driven by market demands and involves collaboration with industry stakeholders. What sets BSI CTMS apart is its comprehensive offering that combines CTMS, eTMF, and Study Startup capabilities into a single integrated platform. Unlike traditional standalone solutions like Excel, which fall short in functionality, our software provides a cohesive experience for users. This integration not only streamlines workflows but also enhances overall productivity in the clinical trial process.

Media

No images available

Media

Integrations Supported

SMART-TRIAL

Integrations Supported

SMART-TRIAL

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

BSI Business Systems Integration AG

Date Founded

1996

Company Location

Switzerland

Company Website

www.bsi-lifesciences.com/solutions/ctms.html

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

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