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Description

An online software solution that employs Quality Risk Management to systematically organize, evaluate, and link Quality data directly to the particular risks associated with patients and pharmaceutical products. Why Choose Us? CINCO is a risk-oriented quality management platform tailored for the Life Sciences sector, offering a paperless method of tracking every critical quality component of a drug or medical device, thus facilitating informed quality decisions at all times. The Importance of Risk Management: Quality Risk Management is a systematic approach that ensures the identification and mitigation of potential risks throughout the manufacturing processes of drugs and medical devices, a method now mandated by most regulatory bodies. Despite its necessity, the traditional paper-based systems prevalent in the Life Sciences Industry fail to effectively handle the wealth of crucial risk information, leading to errors, excessive user friction, and ultimately diminishing operational value. Accessing essential product quality information on demand is vital for enhancing decision-making processes and ensuring safety. By transitioning to a digital system, organizations can streamline their risk management practices and improve overall product integrity.

Description

In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Cinco

Country

Puerto Rico

Website

www.meetcinco.com

Vendor Details

Company Name

OpenText

Founded

1991

Country

Canada

Website

www.opentext.com/info/clinical-trial-management

Product Features

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Alternatives

Alternatives

Medidata Reviews

Medidata

Dassault Systèmes