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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

Integrations

Montrium Connect No 

Integrations

Montrium Connect Yes 

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 

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