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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

Quanticate delivers extensive services in pharmacovigilance, which include the establishment and oversight of safety databases specific to pharmacovigilance. These safety databases act as the primary collection point for individual case safety reports gathered worldwide for a company's pharmaceutical products. Keeping these databases current with the latest regulatory guidelines and ensuring they are validated according to international standards and business requirements is crucial. Quanticate underscores the necessity of choosing the appropriate database by evaluating factors such as the costs associated with implementation and maintenance, the availability of hosting models (including internal infrastructure, third-party hosting, or vendor cloud solutions), previous experiences, and how well they integrate with existing systems. They warn that, despite many commercial databases claiming adherence to standards like ISO ICSR ICH-E2B, achieving genuine compliance necessitates meticulous configuration, validation, and ongoing management. Furthermore, ongoing support and updates are critical to maintain the integrity and reliability of these safety databases over time.

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

Quanticate

Founded

1994

Country

United Kingdom

Website

www.quanticate.com/pharmacovigilance-safety-database

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

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