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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

Argus stands out as the premier and reliable solution for managing, analyzing, and reporting adverse event cases linked to both premarket and post-market drugs, biologics, vaccines, devices, and combination products. Enhance your case management capabilities with advanced features like integrated automation, optimized workflows, and touchless processing options that adapt to your needs. This mature solution ensures compliance with global drug, vaccine, and device regulations and standards, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP, making it a dependable choice for organizations worldwide. With Argus Advanced Cloud, users gain access to Oracle Analytics, an AI-driven tool that not only reveals valuable insights but also enables quicker, more informed decision-making. As medicinal product safety teams navigate the challenges of increased caseloads, diverse signal detection data sources, and evolving regulations, they must do so with limited budgets and resources, making efficient solutions like Argus essential for their success. Ultimately, Argus helps organizations maintain safety and compliance in a complex landscape while optimizing operational efficiency.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

AccelSafety No 
Compier Literature Screening No 
Oracle Analytics Cloud No 

Integrations

AccelSafety Yes 
Compier Literature Screening Yes 
Oracle Analytics Cloud Yes 

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 Yes 
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 Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Clinevo

Country

United States

Website

www.clinevotech.com

Vendor Details

Company Name

Oracle

Founded

1977

Country

United States

Website

www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/

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 

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