Ask the Experts: Computer System Considerations for Pharmacovigilance Data Migration

Adaptive Trial DesignWhen it comes to safety systems, pharmacovigilance professionals must take into consideration the guidelines and legislation laid out my regulatory agencies. Computer systems used to manage safety data are subject to rigorous validation testing to determine if they are suitable to manage safety data in the clinical environment.

Last month, ARITHMOS hosted the second edition of Pharmacovigilance Day in Milan, a seminar which invites pharmacovigilance professionals to meet and discuss the industry’s most pressing issues. This year, a senior PhV Inspector from the Italian Pharmaceutical Association (AIFA) presented his considerations on computerized systems and Inspection-Readiness especially in terms of data migration and the PSMF.

According to the Good Vigilance Practices (GVP) applied in Europe, “facilities and equipment which are critical for the conduct of pharmacovigilance should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. There should be processes in place to keep awareness of the valid terminologies in their valid versions to keep the IT systems up-to-date accordingly”.

This is of utmost importance in the pharmacovigilance field, especially when it pertains to the transfer of safety data from outdated or legacy systems.

What does this mean for the migration of pharmacovigilance data?

More specifically, GVP Module VI addresses the need for a quality management system to ensure compliance with standards and documentation including data collection, transfer and management.

Therefore, there is a need to establish which processes will be used in every step of data migration and who will be involved in the data transfer and their role. Next, the checks that will be carried out after migration next to be defined to guarantee data integrity and completeness in the database. Lastly, a documentation and archiving process needs to be defined.

A quality management process needs to be in place to keep track of the activities done before, during and after the data transfer to ensure that the transfer to the new database is secure and complete and that the processes used did not result in the loss of safety data.

Verifying data migration is essential when:

  • There a new safety database is implemented
  • The acquisition of a new company or the merging of two companies

As our expert points out, data migration is necessary because:

  • Cumulative data in ICSRs are requested for the analysis of signals and for a risk/benefit analysis
  • PSURs, where foreseen, must contain cumulative “summary tabulations” of adverse reactions
  • Regulatory agencies can request cumulative reviews for types of specific events
  • Occasionally follow up information can be requested for previous signaled cases

Additional Considerations for the PSMF

Besides safety databases, the PSMF must report any electronic system that collects, registers and reports safety information including medical information systems, data banks or any other system in clinical trials that collects safety data.

Common deviations for computerized systems include the absence of a disaster recovery and business continuity plan, no reconciliation between the pharmacovigilance database and other department databases and the failure to enter all AEs into the PhV database.

ARITHMOS recommends a full business and technical analysis of pharmacovigilance needs before proceeding with data migration projects. Our multidisciplinary team of business analysts, life science application specialists, pharmacovigilance system and process experts and computer system validation experts can prepare a proper user requirement analysis and a risk management plan to guide companies through data migration projects to guarantee compliance with regulatory standards.

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.

The Biggest Challenge in Pharmacovigilance Today Is….

pharmacovigilance_safety_dataIn an ongoing survey analyzing pharmacovigilance trends, ARITHMOS asked pharmacovigilance and clinical operations professions what they think the biggest challenge facing the field is. Are pharmacovigilance practitioners overly concerned with satisfying regulatory requirements or accurate signal detection?

According to ARITHMOS’ survey, which has been active worldwide for the past 2 months via our website and social media channels, respondents cited costs associated with implementing and maintaining a PhV system and managing vast amount of safety data as the biggest challenges in the industry.

Costs are always a primary concern in the life sciences industry as regulatory requirements become more burdensome while budgets tighten. System implementation and maintenance requires laborious collaboration with IT and business analysts, licensing concerns and regular maintenance checks and upgrades.

ARITHMOS has some tips on managing these difficult pharmacovigilance challenges:

System Implementation & Maintenance

Investing in a pharmacovigilance system or migrating to a modern system can be a huge investment for many companies. Ensuring a high Return on Investment from your system begins in the planning phase. Make sure your system provider has a multidisciplinary team of business analysts, life science application specialists and computer system validation experts in order to define user requirements and prepare a risk management plan.

A cost-effective solution is to implement a cloud-based pharmacovigilance system accessible through the Internet with minimal IT effort. In this scenario, the application can be deployed using the standard validation configuration and then be customized to meet customer needs. Computer systems can cost a company up to $2 million USD plus the additional costs for experts to install and maintain these systems. The Cloud eliminates the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal credentials. Additionally, a cloud computing solution eliminates the need for IT infrastructure such as data centers, significantly reducing costs.

ARITHMOS has also established the Oracle Argus Consortium Initiative for Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of up to 20% cost savings due to the sharing of set-up activities, validation documentation and deliverables. The Oracle Argus system would be released to the customer with a standard configuration which is shared among multiple end users.

pharmacovigilance_cloudManaging Vast Amounts of Safety Data

Again, ARITHMOS stresses the benefits of cloud technology for managing vast amounts of data. Sponsors can organize multi-language, global safety data into a single database which is particularly beneficial for efficient signal detection, safety reports and reporting as well as data analysis.

In order to successfully manage data, ARITHMOS recommends automating signal detection by implementing a reporting tool (for example, SAS) in order to pull and analyze data. The identification of signal criteria and the implementation of standardized programs automates the signal detection process.

However, a key aspect of safety data management is clinical data visualization and ad hoc reporting. The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using data to identify and fix problems. Arithmos can integrate Business Intelligence tools with Data Visualization tools on handheld devices such as smartphones and tablets for safety data on the go. With the changing pharmacovigilance legislation, real time safety data is crucial. Arithmos has data visualization solutions for clinical safety reporting from the best pharmacovigilance databases and systems.

 

Smart Strategies for Pharmacovigilance: Data Migration

CDV1Pharmacovigilance is becoming a more pressing issue in the drug and device cycle, mostly due to increased regulations by the FDA and EMA which are looking to increase patient safety in both clinical development and post-market use. Companies engaging in clinical development need a proper pharmacovigilance system that can manage case processing and vast amounts of data.

ARITHMOS discusses the importance of keeping systems up-to-date and the risks involved in running discontinued systems. Specifically related to pharmacovigilance and end users, ARITHMOS addresses issues associated with using Oracle AERS and Trace, two pharmacovigilance systems that will move from premium support to sustaining support (AERS 4.7 in January 2015, Trace in August 2016) meaning support services are limited and migration is recommended.

During the life cycle of a product, manufacturers produce patches to ensure security, and therefore when the life cycle of a product ends, the manufacturer discontinues full support (or in Oracle’s case, premium support). More importantly and even riskier for end users in the clinical development sector, this could put companies in danger of non-compliance with industry standards and regulations.

In the case of discontinued or outdated software, the service provider can’t keep systems up-to-date and recommend migrating to new versions or platforms.

Smart Strategy: Migrating to Oracle Argus Safety Suite

argus safetyOracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. Oracle AERS premium support will end in 2015, and therefore ARITHMOS recommends a data migration project to Oracle Argus Safety. Argus Safety is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Gold Partner, ARITHMOS can offer Oracle Argus Safety Version 7 as well as migrate safety data from legacy or discontinued systems.

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migrating from a discontinued system starts with a Business Requirement and Configuration analysis through to validation testing and reports.

Due to increased regulation on safety data and  the need to improve data quality, ARITHMOS can guarantee real-time and customized reporting solutions for Oracle Argus Safety including integration with Oracle Business Intelligence.

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