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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
Dialog provides a comprehensive, modular solution for pharmacovigilance literature monitoring, designed to enhance the efficiency of organizations responsible for drug safety reporting by automating and refining the entire process of literature triage. With access to over 140 reputable scientific and medical literature databases, including MEDLINE, Embase, and Biosis, it standardizes the content from various sources, ensuring a consistent approach to precision search, deduplication, and structured XML output. The DialogML engine utilizes advanced artificial intelligence to prioritize search results based on their relevance to patient safety, identifies critical safety concepts, and categorizes references pertinent to ICSRs (Individual Case Safety Reporting), aggregated reports (PBRER, PSUR, DSUR), and safety signals, enabling reviewers to swiftly pinpoint high-priority articles. Furthermore, the Dialog Alerts Manager enhances the process of creating and managing alerts by providing features such as bulk editing options, comprehensive audit trails for changes in search strategies, flexible scheduling, and detailed tracking of delivery histories. This integrated system significantly reduces the time and effort required for effective literature monitoring, empowering organizations to focus more on critical drug safety issues.
API Access
Has API
No
API Access
Has API
No
Integrations
XML
No
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
No
Live Rep (24/7)
Yes
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)
Yes
In Person
Yes
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/dialog/
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