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About

Document management and ensures regulatory compliance in clinical trials. By integrating AI and a unique "co-pilot" feature, our platform boosts efficiency while maintaining human oversight. Automated Filing with AI The AI assistant automates document classification and metadata assignment, reducing manual effort. Co-Pilot for Human Control The "co-pilot" feature allows users to set confidence levels for AI classification. Documents below the threshold are flagged for review, and users can adjust classifications, helping the AI improve. Key Benefits: Efficiency: AI automates tasks, allowing more focus on critical activities. Accuracy: AI and co-pilot oversight ensure data integrity and compliance. User-Friendly: An intuitive interface simplifies document management. Continuous Learning: AI improves accuracy with ongoing user feedback.

About

The market-leading, trusted solution for processing, analyzing, and reporting adverse event cases originating in premarket and post-market drugs, biologics, vaccines, devices, and combination products. Transform your case management efficiency with innovative capabilities, such as built-in automation, workflow optimization, and conditional touchless processing. You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP. Argus Advanced Cloud includes Oracle Analytics, a powerful, flexible, AI-powered solution that empowers users to uncover new insights and make faster, more informed business decisions. Medicinal product safety teams face enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations, all with flat budgets and resources.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

CRO, Biopharma, Medical Devices

Audience

Pharmaceutical companies in need of a tool to manage rapidly increasing caseloads and changing regulations

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$1300.00
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 4.7 / 5
ease 5.0 / 5
features 4.7 / 5
design 4.7 / 5
support 5.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Flex Databases
Founded: 2011
Czech Republic
www.flexdatabases.com/en/

Company Information

Oracle
Founded: 1977
United States
www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/

Alternatives

Alternatives

Castor EDC

Castor EDC

Castor
Clienvo eTMF

Clienvo eTMF

Clinevo
TrialKit

TrialKit

Crucial Data Solutions
TARA PV

TARA PV

MedGenesis
OnCore

OnCore

Advarra
AccelSafety

AccelSafety

Techsol Life Sciences

Categories

Categories

Clinical Trial Management Features

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Electronic Data Capture Features

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

Integrations

AccelSafety
Compier Literature Screening
MainEDC
Oracle Analytics Cloud

Integrations

AccelSafety
Compier Literature Screening
MainEDC
Oracle Analytics Cloud
Claim Flex Databases and update features and information
Claim Flex Databases and update features and information
Claim Oracle Argus and update features and information
Claim Oracle Argus and update features and information