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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 BizNet?

Accelerate clinical innovation with an AI-enabled Clinical Research Platform that unifies Early Phase CTMS, Late Phase CTMS, and Bioanalytical LIMS into a single, intelligent ecosystem. Purpose-built for pharmaceutical, biotechnology, and CRO organizations, the platform streamlines the complete clinical development lifecycle, from protocol planning, volunteer and patient management, site operations, study execution, and sample lifecycle management to bioanalytical testing, data review, and regulatory reporting. AI-powered capabilities such as intelligent workflow automation, predictive analytics, anomaly detection, smart data validation, and real-time decision support help research teams identify risks early, optimize resources, reduce manual effort, and make faster, data-driven decisions. A key differentiator is its unified CTMS-LIMS architecture, eliminating data silos while ensuring seamless data flow, end-to-end traceability, and operational transparency across clinical and laboratory functions. Configurable workflows, role-based dashboards, automated alerts, and enterprise integrations with EDC, eTMF, ERP, and laboratory instruments enhance collaboration and study oversight. Built on a scalable, GxP-compliant framework supporting GLP, GCP, and 21 CFR Part 11, the platform delivers audit-ready documentation, electronic records, secure access controls, and complete data integrity. By combining AI-driven intelligence with compliance, interoperability, and operational excellence, it empowers sponsors and CROs to accelerate trials, improve study quality, and bring therapies to market faster.

Media

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Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$79
Contact Sarjen Systems Pvt Ltd.
Free Version
Free Trial Offered?

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

Sarjen Systems Pvt Ltd

Date Founded

1998

Company Location

India

Company Website

biznet.sarjen.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

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