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What is Cloudbyz Safety and Pharmacovigilance (PV)?

The Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based platform tailored to enhance drug safety and pharmacovigilance for companies in the pharmaceutical and life sciences sectors. This innovative solution automates the entire workflow of data collection, processing, analysis, and reporting in adherence to global regulatory standards. Cloudbyz offers comprehensive management of the pharmacovigilance lifecycle, encompassing adverse event processing, case management, regulatory reporting, signal detection, and risk management. By utilizing Cloudbyz, organizations can streamline their pharmacovigilance operations, expedite case processing, and boost the precision of their safety data, all while mitigating risks and ensuring compliance with regulations. Additionally, the advantages of our solution include: 1. Enhanced efficiency through automation 2. Improved accuracy of data 3. Immediate visibility into processes 4. Better collaboration among teams 5. Strengthened adherence to regulatory requirements Furthermore, adopting this solution empowers organizations to focus on innovation and patient safety, ultimately leading to improved outcomes in drug monitoring.

What is ClinSoft?

ClinSoftâ„¢, created internally by Innovate Research, does not involve any external acquisitions or integrations. The software adheres to FDA regulations, including 21 CFR Part 11, GCP, and HIPAA standards, ensuring it is both fully auditable and validated. This user-friendly system facilitates rapid start-up and close-out processes, allowing you to save valuable time and guaranteeing that any amendments or updates to study protocols are implemented efficiently. As a contract research organization based in India, Innovate Research specializes in clinical research and regulatory affairs, ensuring compliance with US FDA 21 CFR Part 11. The platform features secure electronic signatures and records, role-based access control, and an audit trail. Moreover, it includes an intuitive interface for editing checks and setting up case report forms (CRFs), along with reusable frameworks for items, panels, visits, and pages, enhancing usability and efficiency for clinical trials. Additionally, the comprehensive design of ClinSoftâ„¢ supports streamlined workflows, ultimately improving overall productivity in clinical research operations.

Media

Media

Integrations Supported

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF

Integrations Supported

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Cloudbyz

Date Founded

2014

Company Location

United States

Company Website

www.cloudbyz.com

Company Facts

Organization Name

Innovate Research

Date Founded

2014

Company Location

India

Company Website

innovate-research.com/clinsoft/

Categories and 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

Categories and 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

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