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features
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support

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Description

ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.

Description

Sentria is a cutting-edge platform that utilizes artificial intelligence to manage adverse event cases and conduct post-marketing surveillance. This software solution is user-friendly, highly customizable, and automated, ensuring it meets industry regulations to improve the efficiency, speed, and accuracy of adverse event handling. It supports pharmacovigilance compliance with international ICH guidelines while adhering to local regulatory requirements for the assessment of adverse events. By providing an easy-to-use interface enhanced with pharmacovigilance automation, Sentria minimizes reporting errors through smart alerts and simplifies report processing by employing international coding standards such as MedDRA and ATC/WHO. The platform enhances analytical capabilities through the use of semantic artificial intelligence tailored for pharmacovigilance needs. Notably, Sentria offers features like secure access controlled by user credentials, comprehensive auditable logs to ensure compliance, and a secure encrypted cloud environment for data protection. These functionalities collectively empower organizations to manage adverse events more effectively, contributing to better patient safety outcomes.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Innovate Research

Founded

2014

Country

India

Website

innovate-research.com/clinsoft/

Vendor Details

Company Name

dezzai

Founded

2016

Country

Spain

Website

dezzai.com/en/sentria/

Product 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

Product Features

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