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Description
BeeCTD offers a comprehensive eCTD management system tailored for pharmaceutical companies and regulatory bodies. With its modular design and clear licensing approach, users can select the specific modules they wish to utilize, such as Reader, Compiler, and Validator. The advanced Reader provides insights into the complete lifecycle of the dossier, accommodating both eCTD and NeeS sequences, and facilitates the transition between the two formats, including baseline submissions. Additionally, the real-time sequence validator ensures compliance with the eCTD/NeeS technical specifications, incorporating best practices, while always reflecting the latest validation criteria, with older versions accessible for reference. Users can seamlessly compile their documents into an eCTD-compliant format, leveraging our eCTD compiler tool, which they can use independently or as an on-demand service where we handle the compilation for them. Moreover, the flexibility and scalability of BeeCTD make it an ideal choice for organizations seeking to enhance their regulatory submission processes.
Description
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
API Access
Has API
API Access
Has API
Integrations
Crow Canyon Contract Management
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Altamira
Founded
2009
Country
Slovakia
Website
www.altamira.ai/beectd/
Vendor Details
Company Name
Court Square Group
Founded
1995
Country
United States
Website
www.regdocs365.com
Product Features
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
