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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

DF mSignal is a modular and scalable safety signal management system that enhances the efficiency of signal detection processes and risk management across pharmaceuticals and medical devices. It also includes cosmetics and nutraceuticals. The platform provides active and passive monitoring with real-time monitoring product-event combination, customizable clinical risk indicators, and an interactive interface with advanced analytics. It integrates seamlessly into MedDRA, WHO DD, clinicaltrial.gov and electronic data collection systems, providing a comprehensive safety solution for professionals. DF mSignal AI automates statistical scores to save time and ensure accuracy in signal detection. The system is designed to comply with all applicable regulations, including 21 CFR Part 11, data privacy and integrity controls, as well as GxPs. This ensures compliance and security.

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

Datafoundry

Founded

2016

Country

India

Website

datafoundry.ai/m-signal/

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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