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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
cubeCTMS is an all-encompassing clinical-trial management platform that facilitates complete oversight of trials, encompassing aspects such as tracking study sites and investigators, managing enrollment and visit schedules, and overseeing budget and contract workflows, as well as milestone reporting and document management. By centralizing study operations and automating essential processes, it allows sponsors, CROs, and study teams to oversee progress in real time, coordinate tasks across various studies, enhance communication with sites, and reduce risks. The platform offers integrated dashboards, notifications, and audit-ready documentation to ensure compliance with regulatory standards, including readiness for FDA 21 CFR Part 11, empowering stakeholders to oversee trial timelines, resources, and overall performance from a singular interface. Additionally, cubeCTMS seamlessly connects with other CRScube modules, such as EDC, eTMF, and pharmacy/RTSM, creating a cohesive ecosystem that minimizes redundancy, optimizes data flow, and supports flexible workflows during amendments or large-scale implementations. This integration not only streamlines processes but also enhances the overall efficiency of clinical trials, making it an invaluable tool for research teams.
API Access
Has API
API Access
Has API
Integrations
cubeCDMS
cubeSAFETY
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
CRScube
Founded
2010
Country
South Korea
Website
www.crscube.io/solution/cubectms
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
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