Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Cloudbyz Safety & Pharmacovigilance Solution, a cloud-based solution, is designed to streamline drug safety and pharmacovigilance for pharmaceutical and life sciences companies. The solution automates the process of collecting data, processing it, analyzing it and reporting it in compliance with global regulations. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance. The benefits of our solution are listed below- 1. Improved Efficiency with Automation 2. Increased data accuracy 3. Real-time visibility 4. Improved Collaboration 5. Enhanced regulatory compliance

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF
Montrium Connect

Integrations

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF
Montrium Connect

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

Cloudbyz

Founded

2014

Country

United States

Website

www.cloudbyz.com

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

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

Product Features

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

Alternatives

Alternatives

KnowledgeNET Reviews

KnowledgeNET

Sarjen Systems
LifeSphere RIMS Reviews

LifeSphere RIMS

ArisGlobal
PvEdge Reviews

PvEdge

Sarjen Systems
GlobalSubmit Reviews

GlobalSubmit

Certara