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Average Ratings 0 Ratings

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Description

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.

Description

The Drug Safety Triager, developed by Clarivate, represents an advanced pharmacovigilance tool aimed at helping life sciences organizations adhere to regulatory standards. This system, which is validated for Good Practice (GxP) compliance and prepared for audits, enhances and organizes the workflow associated with literature reviews, allowing pharmacovigilance professionals to prioritize patient safety by streamlining these processes. Fully compliant with the reporting demands of major global safety regulatory bodies, including the FDA and EMA, the Drug Safety Triager includes a comprehensive validation package with every implementation. The validation documentation is carefully constructed to meet the stringent requirements set forth by the pharmaceutical sector and health authorities. Additionally, every piece of literature referenced is subjected to a meticulous review process that ensures all user actions are recorded, creating a permanent, immutable audit trail for accountability and transparency. This innovative approach not only improves efficiency but also reinforces the commitment to maintaining high standards in patient safety and regulatory compliance.

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

Clinevo

Country

United States

Website

www.clinevotech.com

Vendor Details

Company Name

Clarivate

Country

United Kingdom

Website

clarivate.com/life-sciences-healthcare/research-development/pharmacovigilance-drug-safety/drug-safety-triager/

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

Alternatives

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Clinevo CTMS

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Alternatives

Clinevo Safety Reviews

Clinevo Safety

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Dialog Reviews

Dialog

Clarivate