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.

DIA Recap: Arithmos Highlights from Boston

The DIA 49th Annual Meeting in Boston has come and gone, and as a first time exhibitor, Arithmos was pleased to be a part of the show. We enjoyed meeting new contacts and discussing new trends in clinical trials, especially technology solutions. Here are some of the highlights from our week in Boston:

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1. Pharmacovigilance – Safety Databases and Reporting

As clinical trial technology experts, we aim to keep up with trends in the industry. We met many contacts who are interested in building automatic safety databases with real-time access to safety data.

2. Introducing ArithmosCentrum to the American market

Arithmos has developed an Enterprise Resource Planning system for CROs which combines sales, project management, finance and resourcing. We had the opportunity to introduce this product to the American market at DIA and demo AC for several CROs.

3. Networking Event at the New England Aquarium

Arithmos joined CROS NT and Kubo Recruitment in hosting a networking event at the New England Aquarium. We would like to thank all those who joined us for a great evening!

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4. Raising Money for One Fund Boston

Arithmos joined in CROS NT and Datatrak’s mission to raise money for One Fund Boston – a fund which supports victims of the Boston Marathon bombings. We helped sell t-shirts in which all proceeds went to One Fund Boston. We are pleased and proud to announce that $1,615 was raised and the money was donated to One Fund today!

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Overall, Arithmos is pleased with its DIA experience and we are looking forward to next year’s show in San Diego! For more information on our clinical trial technology services, visit http://www.arithmostech.com. 

Integrating ePRO Devices into your EDC System

The growth of EDC is driving the adoption of ePRO (Electronic Patient Recorded Outcomes) as clinical site staff are recognizing the benefits of using an integrated ePRO/EDC solution. Arithmos discusses how to integrate intuitive ePRO devices with an EDC system.

According to a survey conducted by Arithmos last year, clinical trial leaders cited immediate feedback, more accessible information and higher quality data as the main reasons for using EDC over paper. In recent years, there has been an increasing trend towards the use of electronic data capture due to its many benefits, such as:

  • Less administrative and cost-effective
  • Quicker data cleaning process, reducing Data Management costs
  • Increase of patient compliance
  • Full integration with ePRO devices
  • Real-time data so trial leaders can make more educated and adaptive decisions
  • Multi-language and global study data in a single database
  • Market shifting towards user-friendly ePRO devices
  • Devices with “apps” allow access to resources and medical information

ePRO solutions

Integration: ePRO and EDC

The integration of clinical systems puts all patient data into one system for easily accessible study results. Integrating Patient Recorded Outcomes and Case Report Forms into an EDC system produces the following benefits:

  • Reduces the risk of trial delays by eliminating discrepancies which saves time and, inevitably, cuts expenses
  • Synchronization of data to offset conflicts in two isolated datasets

Clinical trial leaders – including Monitors and Investigators – are concerned that the time required for integration will cause trial delays. However, there are Good Practice Designs and basic standards for eClinical integrations to reduce time and costs.

Integration should support data transfers in real time to eliminate the chance of outdated datasets and discrepancies, and integrated systems require a central database to store data for all trial subjects.

ePRO devices and EDC system integration requires minimal work and material. To connect the ePRO device to the EDC system, there needs to be an Internet connection such as wireless, bluetooth or plug-in as well as HTTPS on the Internet and a web server.

CDISC and the Operational Data Model (ODM) calls for XML-based formats that can accommodate all data values. Integration using industry standards is the best bet for real time views of global study progress.

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For a detailed look at ePRO devices, see our previous post “Mobile Apps and Tablets Take Over Clinical Trials”

Arithmos Experience

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Arithmos has extensive experience on the integration and validation of ePRO solutions for Oracle Clinical RDC as well as the assessment of data and patient diaries. We also have strategic partnerships with mobile and tablet experts for intuitive devices such as the iPad and Blackberry.

Arithmos has completed several EDC studies in therapeutic areas such as Respiratory, Neurology, Gynaecology, Cardiovascular, Oncology, Renal and Circulatory. In a Phase III Respiratory study with over 2000 patients in 175 sites, Arithmos integrated a spirometric device with RDC where 2 daily spirometric tests were performed and QoL diary data was collected. More recently, in a post-market dermatology study with 300 patients in 21 sites, Arithmos integrated a questionnaire on the iPad 2 to collect patient data.

Mobile “Apps” and Tablets Take Over Clinical Trials

The mobile and “apps” market has been growing rapidly and steadily for the past few years. With the introduction of the iPad in 2010, the tablet market is gaining attention as product value soars in many industries. Health and pharmaceuticals is one of those industries openly accepting the mobile and tablet takeover as these devices and their “apps” bring added benefit and new innovative solutions. In a follow up to last week’s post, Arithmos discusses the market and how devices are being integrated. 

Market Overview

iPad_Tablet_for_HealthCare (1)A snapshot of the overall market emphasizes the importance of embracing these technologies. In 2011, there were over 491 million smartphones sold worldwide. To clarify, a smartphone combines the capabilities of a mobile phone with PDA (personal digital assistant). Many of these smartphones include “apps”. The Apple store alone has over 500,000 “apps” which can be easily created by consumers. The tablet market has the fastest market growth rate, with the Apple iPad owning the majority of the market share. Apple recently reported that over 65% of Fortune 100 companies are using or testing the iPad for use within the company.

The pharmaceutical industry has been embracing these markets for several reasons. One of the biggest reasons is patient compliance. Patients want the “WOW Factor ” – the digital and personalized experience.

Devices such as tablets and smartphones can cut clinical trial costs as well. Setting up desktops or laptops, or even printing paper, can be more expensive than simply downloading information on a device. Using these devices also allows patients to just send information via click or an IM/SMS. With the installation of  “apps”, medical information can be downloaded instantly by doctors or Investigators.

Investment by the pharma industry in wireless devices has grown 78% in the past year. Reference “apps” like WebMD are most popular, and “apps” are used for compliance, consent and even diagnosis.

Devices

What are some of the most noteworthy mobiles, tablets and “apps” in use today in clinical trials? 

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The Blackberry (BB) allows users to be identified via PIN which helps confirm patient compliance. Data can be transmitted via SMS, Blackberry Messenger (BBM) or Bluetooth technology. The BB allows for instant data transmission and instant communication between patient and Investigator. For clinical trials in diabetes (one of the fastest growing therapeutic areas in pharma), a glucometer can be connected via Bluetooth to a BB Curve model to transmit data.

The iPad and iPhone are garnering attention in the patient compliance area. The touch screens and “apps” make these Apple devices popular and easy to use. Patients are identified via username and password and Bluetooth technology is enabled.

See our last blog post: Clinical Trials & Business Intelligence: iPad and iPhone Revolution

The top Pharma “apps” are currently: WebMD, Novartis GIST Calculator, Roche Nursing ACE, Merck iChemoDiary and Sanofi-Aventis GoMeals for Diabetes patients.

Arithmos has extensive experience implementing such devices into the clinical trial process for collecting patient data. These ePRO devices increase patient compliance and can be integrated with an EDC system as well. Arithmos has experience using Blackberry and the iPad for questionnaires and data collection.

Related Links

Arithmos ePRO Solutions

Arithmos Electronic Data Capture Solutions