+
+

Related Products

  • Qualio
    841 Ratings
    Visit Website
  • SDS Manager
    4 Ratings
    Visit Website
  • HSI Donesafe
    152 Ratings
    Visit Website
  • flowdit
    26 Ratings
    Visit Website
  • Lockbox LIMS
    68 Ratings
    Visit Website
  • Certainty Software
    78 Ratings
    Visit Website
  • Predict360
    18 Ratings
    Visit Website
  • Skillcast
    1,105 Ratings
    Visit Website
  • WorkBright
    424 Ratings
    Visit Website
  • MedRight
    22 Ratings
    Visit Website

About

Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. 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.

About

K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Clinical Trial Sponsors, CROs, Clinical Sites

Audience

Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

€8,500 one-time payment
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Cloudbyz
Founded: 2014
United States
www.cloudbyz.com

Company Information

K2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html

Alternatives

Alternatives

PvEdge

PvEdge

Sarjen Systems
PvEdge

PvEdge

Sarjen Systems
AIFMD Annex IV Reporting

AIFMD Annex IV Reporting

Matterhorn Reporting Services

Categories

Categories

Clinical Trial Management Features

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Integrations

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF
Microsoft SharePoint

Integrations

Cloudbyz CTMS
Cloudbyz EDC
Cloudbyz eTMF
Microsoft SharePoint
Claim Cloudbyz Safety and Pharmacovigilance (PV) and update features and information
Claim Cloudbyz Safety and Pharmacovigilance (PV) and update features and information
Claim K2C PSMF Solution and update features and information
Claim K2C PSMF Solution and update features and information