MainEDC

MainEDC

Data Management 365
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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

Complex eClinical Solution for EDC/ERT/eCOA that significantly speeds up the start of clinical trials (up to 5 days), saves budget (up to 80% for monitoring), increases the capitalization and attractiveness of your company (noted by 89% of customers). Increases the knowledge and advancement of Data Management and Data Science professionals (noted by 96% of specialists). 94% of investigators like the usability of interfaces. An important part of Data Management 365 policy is to have strong internal competence in Clinical Data Management and Data Science. This allows our company not only to deeper understand the challenges that Data Managers face in their work and make the MainEDC™platform better using the online feedback but also to provide the transfer of technology and best practices to our Clients.

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 Supported
iPad Not Supported
Android Supported
Chromebook Not Supported

Audience

CRO, Biopharma, Medical Devices

Audience

CROs, Pharmaceutical, Bio-pharmaceuticals, Medical Devices Companies, Life Sciences Research Laboratories and Pharm Marketing Companies

Support

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$1300.00
Free Version Not Supported
Free Trial Supported

Pricing

$399.00/month
Please see our web-site
Free Version Supported
Free Trial 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 4.9 / 5
ease 5.0 / 5
features 4.9 / 5
design 4.9 / 5
support 5.0 / 5

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.

Pros & Cons from Real Users

Pros

  • Rich in features and created by industry experts. Working with imaging (MRI, KT) is amazing. We like the platform.
  • Is equally efficient for dms, scientists and managers. This platform is for supervising complex projects.
  • Opportunity to work faster. 24/7 English-speaking support. Excellent functionality. MainEDC indeed accelerates clinical trials.
  • Helpful in every detail. The platform helps to solve a lot of problems when creating projects. We are very happy.
  • Talented development team and support crew, high-end functionality, intuitive interface. The platform is our indispensable helper.

Cons

  • We haven't implemented RBM, it takes time. No more cons.
  • Your boss might fail to understand the potential of MainEDC until the staff begins to work with it.
  • Complexity for small academic research. If you lack experience in using such platforms, you’d better start with a simpler one. The target audience of MainEDC is people who already know the basics of CDM.
  • Can’t mention any after three months of using. We believe that this will continue...
  • No. We can not single out any shortcomings of this platform, I hope it will continue to be so.

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

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

Company Information

Data Management 365
Founded: 2015
United States
datamanagement365.com

Alternatives

Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics

Alternatives

Trimble CoPilot

Trimble CoPilot

Trimble Transportation
TypeAce

TypeAce

Toh Kar Le
Co-Pilot

Co-Pilot

FIX Flyer

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 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 Supported
Document Indexing Not Supported
Forms Management Supported
Remote Capture Supported
Study Management Supported

Integrations

Flex Databases Not Supported
MainEDC Supported

Integrations

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