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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 CINCO?

An online software platform designed to implement Quality Risk Management effectively organizes, assesses, and connects quality data to the specific risks related to patients and pharmaceutical products. What Sets Us Apart? CINCO is a risk-focused quality management solution crafted specifically for the Life Sciences industry, providing a digital alternative for monitoring every essential quality aspect of drugs and medical devices, thereby enabling well-informed quality decisions consistently. The Significance of Risk Management: Quality Risk Management offers a structured methodology that guarantees the identification and reduction of potential risks throughout the production processes of drugs and medical devices, a practice that is now a requirement for most regulatory agencies. Even though it is imperative, conventional paper-based systems commonly used in the Life Sciences sector struggle to manage the extensive amount of critical risk data, resulting in errors, increased user difficulty, and a loss of operational efficiency. Accessing vital product quality information promptly is crucial for improving decision-making and maintaining safety standards. By adopting a digital framework, companies can enhance their risk management strategies and boost overall product reliability. This transformation not only optimizes operational workflows but also fosters a culture of continuous improvement within organizations.

Media

No images available

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 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

Cinco

Company Location

Puerto Rico

Company Website

www.meetcinco.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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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