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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

OpenSourcePV is a company founded by Lionel Van Holle in 2019 with the ambition to make use of free & open source technologies to raise the standards of pharmacovigilance and provide an affordable & competitive alternative to expensive software specialized in pharmacovigilance. To meet their regulatory obligations, pharma companies need to monitor the safety of their products. When they start to have a strong pipeline and multiple products on the market, the amount of data to be reviewed is soon too large to be reviewed manually. To benefit from quantitative analysis, they currently have two options: either they use an expensive suite of tools or they try to build something on their own. With OpenSourcePV, we accompany their journey in quantitative signal detection allowing them to benefit from pre-built modules and building something customized to their specific needs and data sources.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

CRO, Biopharma, Medical Devices

Audience

Healthcare and pharmaceutical enterprises in search of a solution to monitor product safety and perform quantitative signal detection

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$1300.00
Free Version Not Supported
Free Trial Supported

Pricing

Free
Free Version Supported
Free Trial Not Supported

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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Pros & Cons from Real Users

Pros

  • The system has every feature that CRO may need. eTMF and EDC is implemented which saves money. Once Flex Databases is implemented you will no longer concern about regulatory issues.
  • CTMS was implemented really fast. Learning process is excellent. eTMF integrated - helps to save lot of money. The platform has it all.
  • Clinical Trial Management System, Document Management, Patient Management, Patient Monitoring, and Randomization are some of the features provided by Flex Database.

Cons

  • Wasn't so easy to understand everything through companies' website. Better book a call.
  • Nothing to complain about. The platform is operates excellently.
  • Quite costly, not available on Windows and Mac. Only available on the cloud as SaaS.

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

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

Company Information

OpenSourcePV
Founded: 2019
United States
www.opensourcepv.com

Alternatives

Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics

Alternatives

Trimble CoPilot

Trimble CoPilot

Trimble Transportation
Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics
TypeAce

TypeAce

Toh Kar Le
PvEdge

PvEdge

Sarjen Systems
Co-Pilot

Co-Pilot

FIX Flyer

Categories

Categories

Pharmacovigilance Supported

Clinical Trial Management Features

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

Electronic Data Capture Features

Audit Trail Supported
CRF Tracking Supported
Data Entry Supported
Data Verification Supported
Distributed Capture Supported
Document Imaging Not Supported
Document Indexing Not Supported
Forms Management Supported
Remote Capture Not Supported
Study Management Supported

Integrations

MainEDC Supported

Integrations

MainEDC Not Supported
Claim Flex Databases and update features and information
Claim Flex Databases and update features and information
Claim OpenSourcePV and update features and information
Claim OpenSourcePV and update features and information