5 Reasons Clinical Data Visualization Matters for Pharmacovigilance

ARITHMOSModern communication technology has recently reported that according to an ongoing survey on pharmacovigilance challenges, the management of vast amounts of safety data is an uphill battle for Sponsors.

Data Visualization, which is the concept that data can be structured and viewed through visual representation such as charts and graphs, can facilitate safety data analysis. A strategy of data collection and business intelligence tools can allow Sponsors to make sense of safety data collected in order to make important, and even on-the-go, decisions.

Here are five reasons why Sponsors should be considering clinical data visualization tools for the effective pharmacovigilance management.

1. Access to Data from Multiple Sources

As clinical trials today are often complex in nature and can be conducted on a global scale, data can be spread across multiple sources including databases, eClinical systems (EDC, CTMS, etc) or even across multiple vendors. Data Visualization tools now make it possible to collect safety data from multiple sources and display the data in a structured format for the pharmacovigilance team. The analysis team has the ability to drill-down data and click-through multiple levels of details.

2. No technology or assistance required

Data Visualization tools today are generally based in cloud computing mode. That makes it easier for Sponsors to implement these tools without the technology hassle of HTML or plug-ins. As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications and maintaining applications.

3. Ad-Hoc Reporting & Dashboards

The customization of data visualization tools means that clinical trial leaders can look past the “big picture” and see the specific metrics that matter to their studies. A customizable dashboard allows the pharmacovigilance team to create ad hoc reporting tools for metrics related to safety data and patient management.

4. Real-Time Results

Perhaps the biggest benefit to data visualization is the ability to see and analyze safety data metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise, for example when adverse events are entered. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions.

Cloud-based solutions allow business intelligence tools to be integrated with eClinical tools such as pharmacovigilance systems. This means that pharmacovigilance leaders can have safety data metrics available on their smartphone or tablet wherever they are.

5. Eliminate the Burden; Consider Business Process Services (BPS) Partnerships

Data Visualization in cloud computing mode is a worthwhile investment as it eliminates the burden on the pharmacovigilance team to maintain software systems. The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze safety data immediately and using that data to identify and fix problems.

If Sponsors consider a BPS approach – in which companies engage in licensing contracts with a third party vendor for back-office functions or front-office activities – they can have access to an expert IT infrastructure without the burden and investment. For example, ARITHMOS is part of the Oracle BPS partnership which allows the company to use and understand Oracle applications and offer an optimum value package to clients.

ARITHMOS can install the Oracle Business Intelligence application and integrate it with pharmacovigilance systems for real-time reporting. Oracle BI provides the BI Publisher “app” for iPhone and iPad which is available for free download in the Apple iTunes store. The installation of Oracle BI Mobile to the iPhone/iPad is a straightforward configuration to the BI Publisher. Communication is secure through HTTPS, and users have personal log-in information. Using Oracle BI as a data visualization tools covers all the core components of data visualization: web-based in the cloud, access to multiple data sources, data in real-time, specific safety data metrics and personalized dashboards and ad-hoc reporting.

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ARITHMOS Announces Pharmacovigilance Day 2013

ARITHMOS, with the support of Oracle, is hosting the first annual Pharmacovigilance Day this autumn to address the challenges of pharmacovigilance for pharmaceutical, biotech and medical device companies as well as CROs. This event is a workshop on modern pharmacovigilance technology solutions concerning both European Union regulations and improving operational efficiency for pharmacovigilance management processes.

The workshop is taking place on Tuesday, 12th of November in Milan, Italy. This event is free of charge but limited seats are available, and the expert panel will present in both Italian and English. 

Milano

Why a focus on Pharmacovigilance?

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The European Union and the European Medicines Agency (EMA) have taken steps to improve patient safety in clinical trials based on the startling fact that 200,000 patients die each year from Adverse Drug Reactions. Companies are faced with the challenge of finding solutions that can improve the quality and analysis of safety data while managing the increase in quality of data and the need to satisfy regulatory requirements.

The latest pharmacovigilance regulations – known as Good Pharmacovigilance Practice (GVP) – went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports (ICSRs). Due to the increased regulation on safety data and the need to improve data quality, pharmacovigilance becomes very data intensive and difficult to manage.

The workshop features a panel of experts who will discuss the implementation of technology solutions for meeting the following challenges:

  • Pharmacovigilance Regulations
  • Pharmacovigilance Databases
  • Cloud-based solutions for Pharmacovigilance
  • Safety Data Migration
  • Regulatory and Customized Reporting
  • Signal Detection

Workshop speakers include experts on pharmacovigilance systems including Robbert van Manen of Oracle, Mike Roberts, an Argus Safety expert from Pink Octopus Consulting, Marco Bulleri of Abiogen and Gianluigi Albertini and Stefano Piccoli of ARITHMOS who will do a joint presentation on leveraging cloud technology in pharmacovigilance and the challenges of compliance.

To read presentation abstracts and the biographies of the presenters, visit the Pharmacovigilance Day website:

In English
In Italian

For more information on the event including registration, follow the links below:

In English
In Italian