Pharmacovigilance

Pharmacovigilance Workflow Management: zenflow

zenflow is a safety operation integrated system developed by CAC Croit.
It centrally manages a variety of pharmacovigilance (PV) service-related operations to ensure smooth operation and cost reduction.
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CSV consulting services

We can propose a plan optimized to meet your system size or risk concerns based on our extensive experience. You can choose from a wide range of system lifecycle services from system implementation and preparation through to the operational phase and disposal.

CSV support service for system implementation

Support for validation in implementing systems such as for clinical development, pharmaceutical application, postmarketing surveillance, and pharmacovigilance.

Pharmacovigilance support service for the three regions (US, EU and Japan)

We provide support to a customer who plans to launch their product overseas or to review customer’s global process due to replacement of global drug safety database.

Pharmacovigilance support service

We offer outsourcing service through best suited procedures, depending on the requirements of your company.
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Global PV consulting services

Consulting services for our customers who will release new products outside Japan, or who will revise operational processes due to system changes. Conducted by our staff member who has experience designing global operational processes in a pharmaceutical company.

Consulting Services for LCM, Medical Science, and RMP

By selecting the best healthcare databases, providing optimized consulting services when required, and improving efficiency with the IRV, we will help you to achieve complete life cycle management.

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Medical Science Services for Real World Data Study

We provide medical science services for real world data study in all processes involved in developing and conducting a protocol (framing a hypothesis, designing study, analysis, and writing papers) as follows.

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E2b Editor

This tool enables the creation of a SGML file of E2B (R2) data for reporting to PMDA and for sharing between companies involved.

Important Risk Visualizer® for RMP

Benefits from offering a safety or medical affairs department a list of critical risk information in all required safety specification allow customers to have panoramic grasp of safety countermeasure situation and effective support of activities based on Risk Management Plan (RMP).

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Important Risk Visualizer® for RMP[PDF:3,941KB]

Post-Marketing Surveillance

Data Mining

Signal Detection

Statistical Methods

Spontaneous Reporting Database

Vigilia –Early Post-marketing Phase Vigilance (EPPV) packaged system

This software application provides strong support for Early Post-marketing Phase Vigilance services with functions such as adding visit schedule, creating implementation record, progress management, etc.

Vigilia – Communication management system for “information on proper use”

This packaged software ensures communications of “information on proper use,” even when there are multiple subjects of “information on proper use” which need to be implemented in parallel.


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