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Viedoc PMS (Japan)

Post-marketing surveillance management for Japan, including booklet data collection and Kaifu functionality.

Solution by Viedoc
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Overview

Viedoc PMS is a post-marketing surveillance software solution developed specifically for the Japanese market. It is designed to fulfill all country-specific PMS study requirements, including booklet data collection and Kaifu functionality. The solution is intended for clinical operations teams involved in PMS studies in Japan, combining PMS management and compliance tools within Viedoc's existing EDC environment.

The platform integrates Viedoc PMS with Viedoc EDC, providing a single application for data collection, process management, reporting, and review. It aims to reduce time and effort for sponsors and sites while maintaining compliance and audit readiness throughout the study lifecycle.

Core PMS Capabilities

  • Supports booklet data collection as required by Japanese PMS regulations
  • Includes Kaifu process management functionality specific to the Japanese market
  • Provides reporting and review tools within a single application
  • Maintains compliance and audit readiness across all study steps

Study Progress and Oversight

  • PMS-specific dashboards for monitoring study progress
  • Integration with external progress management systems
  • Oversight tools designed to give sponsors and clinical operations teams confidence and control over ongoing studies

Query and Review Management

  • Flexible query management functionality
  • Supports assignment of review responsibilities between sites and sponsors
  • Designed to ensure transparency and accountability across all parties involved in a study

EDC Integration

  • Viedoc PMS is built on top of the Viedoc EDC platform, which provides electronic data capture management
  • The combined solution covers data collection, query management, reporting, and monitoring within one environment
  • Supports multiple user roles including data managers, investigators, and sponsors

Viedoc PMS (Japan) is offered alongside Viedoc EDC as part of Viedoc's product suite. The solution is tailored to meet the regulatory and operational requirements of post-marketing surveillance studies conducted in Japan, and is positioned for use by sponsors and clinical operations teams managing PMS compliance in that market.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Post-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP