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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

One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system.

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

Clinical research organizations searching for a powerful Trial Management platform

Support

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

Support

Phone Support 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

No information available.
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 Supported

Company Information

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

Company Information

Datatrial
Founded: 1999
United Kingdom
www.datatrial.com/nucleus/

Alternatives

Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics

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Nucleus One

Nucleus One

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Trimble CoPilot

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TypeAce

TypeAce

Toh Kar Le
Nucleus

Nucleus

Momentive Software
Co-Pilot

Co-Pilot

FIX Flyer
Nucleus RTOS

Nucleus RTOS

Siemens Digital Industries Software

Categories

Categories

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

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
Enrollment Management Not Supported
HIPAA Compliant Supported
Monitoring Supported
Patient Database Supported
Recruiting Management Not Supported
Scheduling Supported
Study Planning 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 Datatrial Nucleus and update features and information
Claim Datatrial Nucleus and update features and information