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.


Automation and Traceability Tech Tools for CDISC Mapping Projects

male doctor holding tablet pc with medical appMany pharmaceutical and biotechology companies use CDISC standards when creating databases for new clinical studies. The FDA has recently stated that it “will develop guidance for the industry on the use of CDISC data standards for the electronic submission of study data in applications”.

Adopting and implementing CDISC standards can increase drug development analysis costs. However, identifying the right process for implementation and choosing the appropriate technology can reduce the costs of adopting these standards, making it a very worthwhile investment. ARITHMOS looks at some technology considerations.

Automating Tools to Ensure Consistency

Establishing the correct workflow to manage this CDISC implementation process is the first key step. Sponsors should look at automation tools to create standard data sets to ensure speed and consistency. There are commonly available software applications – for example, SAS can be used to convert Excel data sets and apply metadata attributes to the CDISC domains.

Data Repositories for Information Management and Cost Reduction

Implementing CDISC standards means adopting technologies that can manage the flow of data and information. Keeping clinical data in multiple repositories can create a complex management process and is often prone to error. Managing multiple repositories can mean spending more time on vendor management.

Setting up a central database for all data – whether from a laboratory, a CRF or an ePRO device – to be stored in one place, allows for an easier mapping process. With a centralized hosting system, the process is linear and traceability is under control. A centralized system also provides easy data transfer to the Sponsor, Regulatory Authority or Purchaser.

Benefits to Hosted and Centralized Storage:

  • Cost: Avoid paying multiple CROs or technology providers to set up a global library, program macros and perform validation checks
  • Efficiency and Time: When the team is already familiar with Sponsor requirements the review cycle reduces. Training and HelpDesk costs also reduce.
  • Quality: Measurement scales, design features, outputs and summaries all become standardized.
  • Access to Data: Reporting and access to data becomes much more straightforward. Central web access can be used by sponsors to obtain important safety information, efficacy data and study progress reports.
  • Information in a single point of storage/database
  • One audit trail data source
  • Same location for study data and derived data
  • Traceability is possible from beginning to product submission and market authorization
  • One portal for real-time reports
  • Reporting availability on devices: laptops, tablets, smartphones, etc.

downloadClinical Data Visualization to support CDISC

Clinical Data Visualization and Business Intelligence analytics can support CDISC mapping projects if data is spread across multiple databases and sources. These tools can collect the data from multiple or disparate databases and display the data in a structured format.

The customization of data visualization tools means that clinical trial leaders can see specific metrics that matter to their study as well as see data in real time and “on the go”.