Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Discover a comprehensive platform designed for researching, documenting, and organizing your clinical data seamlessly. The Nucleus platform streamlines your research data management, providing a unified space for storing study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can efficiently manage documents and maintain version control for your quality documentation and media assets. Easily oversee, manage, and share your organizational content without hassle. Additionally, effortlessly compile and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding facilitates dictionary term coding for both MedDRA and WHODrug dictionaries, available as a standalone application or integrated within your data capture system, ensuring flexibility and efficiency in your coding processes. This comprehensive solution not only enhances data integrity but also optimizes collaboration across your research teams.
Description
RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.
API Access
Has API
No
API Access
Has API
No
Integrations
Montrium Connect
No
Pricing Details
No price information available.
Free Trial
No
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Datatrial
Founded
1999
Country
United Kingdom
Website
www.datatrial.com/nucleus/
Vendor Details
Company Name
Montrium
Country
Canada
Website
www.montrium.com
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
Yes
Monitoring
Yes
Patient Database
Yes
Recruiting Management
No
Scheduling
Yes
Study Planning
Yes
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
Yes
Electronic Signature
Yes
Email Management
No
File Recovery
Yes
File Type Conversion
Yes
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
Yes