PcVmanager - Pharmacovigilance Management Software

The most cost effective solution for effortless drug safety compliance

The requirement to fully understand the risks and benefits of pharmaceutical products through all phases of their lifecycle has fueled the need for more efficient and effective pharmacovigilance software solutions to protect patients and manufacturers against risk and ensure regulatory compliance.

Maintaining pharmacovigilance data is a mandatory, yet time intensive and costly process that ultimately contributes little to your company’s bottom line revenue. As such, the need to minimize these costs, yet remain compliant is crucial to your business success.

EXTEDO’s PcVmanager is a comprehensive, cost effective and easy to deploy software solution designed to streamline your pharmacovigilance processes. It enables you to classify, create, review, submit and maintain pharmacovigilance data and adverse event reports within a single, easy-to-use application.

Benefits

  • Track submission deadlines
  • Multi-tenant functionality for the creation of separate data environments
  • Compliant with relevant drug safety regulations
  • Cost effective PV software solution
  • Single database for pharmacovigilance data
  • Quick to install with no need for customization
  • Easy to use with only little training effort
  • Leverage existing IT infrastructure
  • Supports different database back-ends
  • In-house software installation or hosted solution
  • Integrated E2B gateway solution
  • Bi-directional data exchange
Intuitive maintaining of cases - click to enlarge

The simplest way to be compliant with current and future drug safety regulations

Based on the E2B and MedDRA industry data standards, PcVmanager is a tool designed to help you handle the reporting of all serious and non-serious adverse events and manage the lifecycle of mandatory SUSAR and ICSR reports. Through its integrated E2B gateway, PcVmanager provides you with a direct link to the regulatory authorities and also provides the ability to integrate data from core business applications.

PcVmanager is fully compliant with the following regulatory guidelines:

  • ICH, EMA and FDA regulations and directives related to reporting of an Adverse Event
  • EU GMP Annex 11
  • US FDA 21 CFR part 11
  • EMA’s Good Pharmacovigilance Practice (GVP) guidelines

 

In addition, PcVmanager also enables you to readily track and monitor the status of workflows; flagging critical events such as submission deadlines. Its email notifications and visual flags within the online dashboards provide reminders to users about imminent activities they need to perform.

Simple to install and configure

Being out-of-the-box software, PcVmanager is easy to install and requires no customization. This saves you significant time and resources. Depending on your exact needs, PcVmanager can be configured and validated within less than a week. Its simple, intuitive and user-friendly interface ensures ease of adoption amongst users, thus eliminating the need of investing in further trainings. And through its multi-tenant functionality, PcVmanager allows for the creation of separate data environments for external affiliates, partners, or customers.

Used by more than 60 small and medium-sized organizations, EXTEDO PcVmanager is the simplest and most cost effective way to ensure effortless compliance with current and future drug safety regulations.

Downloads

PcVmanager Product Information

PcVmanager Case Study Pharmathen

PcVmanager Case Study Genericon

PcVmanager Case Study Ludwig

E2B(R3) - Challenges and Opportunities

Pharmacovigilance Services

EXTEDO also offers Pharmacovigilance Business Process consulting services, which are tailored specifically to your needs. Based on many years of experience working with drug safety rules and regulations, EXTEDO´s team will help you to identify gaps in your pharmacovigilance processes and help you to develop and implement appropriate strategies PSMF to resolve them.

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Technical Consulting

Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.

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Education & Training Services

To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.

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