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.

Arithmos Integrates Oracle AERS with Business Intelligence; Investing in Pharmacovigilance

Arithmos has been investing in technology developments to meet the needs of the pharmacovigilance market, in particularly the need to make data more readily available. The Arithmos team recently integrated Oracle AERS and Oracle Business Intelligence to meet a specific need in the pharmacovigilance market: to provide a user-friendly platform that allows real-time access to structured data. As an Oracle Business Process Outsourcing Provider, Arithmos can use and understand Oracle applications to offer a premium value package to its clients.

oracle business intelligence

Defining the Need

The Oracle AERS and Business Intelligence integration is an investment in outsourced pharmacovigilance work which requires the need to access real time data and results. The current process involves an Oracle9i database and periodical reporting through SAS which publishes reports in a web page. However, the data is not always available in real time, therefore Arithmos has identified the following user requirements:

  • Accessibility to live data anytime, anywhere in accordance with regulatory requirements
  • Aggregated data: the ability to navigate, modify and interact with results
  • A flexible platform and an easy-to-use interface

Arithmos’ Solution

pharmacovigilance technologyThe proposed solution by Arithmos is an integration of the Oracle9i database with Oracle Business Intelligence Standard One edition which creates an Oracle interactive dashboard that allows companies to constantly access data and results.

The implementation process requires building a Business Intelligence repository, analyzing data and publishing data on the Dashboard. An ODBC connection is required to import Oracle AERS data into an Oracle BI repository where there are 3 layers: Presentation Object, Logical Business Model and Physical Data Sources.

The Oracle BI Dashboard management allows customization of paye layout according to user requirements. A web interface allows access to the “Answer” section where queries, charts and format views can be created. The Dashboard is interactive, which allows companies to access live data corresponding to user requirements.

Why invest in Pharmacovigilance?

The pharmacovigilance market is expected to grow to $2.2 billion USD by 2015, according to a Frost & Sullivan report (World Pharmacovigilance Markets in Lifesciences). The FDA adnd EMA have increased regulations on drug safety, and in an effort to cut costs, pharmaceutical companies are outsourcing drug safety work.

A burdening cost for most companies is technology and the migration of data from one system to another. The pharmacovigilance market will benefit from system integration that provides readily available data and results.

Arithmos and Pharmacovigilance

oracle-gold-partner-logoAs an Oracle Gold Partner and BPO partner, Arithmos can provide the licensing for Oracle AERS and Oracle Business Intelligence and take care of the implementation and integration. A Business Intelligence licensing solution is recommended for companies in which:

  • Staff is not familiar with database navigation
  • Real time and constant access to data is necessary
  • In-depth data analysis is necessary

Related Links

Arithmos Pharmacovigilance Services

Arithmos Solutions – AERS vs Argus

Automating Signal Detection to Efficiently Manage Safety Data