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of utmost importance in the pharmacovigilance field, especially when it pertains to the transfer of safety data from outdated or legacy systems.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

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.

 

In Copenhagen, Technology is the Focus of Nordic Life Sciences Events

Next week, ARITHMOS is in Copenhagen to sponsor to life sciences events that focus on evolving trends in the clinical trials sector – pharmacovigilance and Risk-Based Monitoring. Technology takes center stage when looking to implement solutions that can ensure data quality, improve efficiency and cut costs.

Nordic Pharmacovigilance Day
7th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Pharmacovigilance Day focuses on “designing an efficient pharmacovigilance system” and how the use of electronic systems can help companies achieve the effective safety system required by law, especially under the new GVP guidelines.

ARITHMOS has pointed out before that the system you choose should be compliant with global adverse event reporting standards as well as with standards of main regulatory bodies. For example, the EU has relased good pharmacovigilance practice guidelines (GVP) which focuses on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

  • Does the system have technologically advanced reporting tools?
  • Is the system intuitive?
  • Is the system available in the cloud?
  • Does the system have the appropriate coding functions?
  • Who will take care of the hosting, validation and maintenance?

Speaking of pharmacovigilance in the cloud, Pharmacovigilance applications should be accessed through the Internet with minimal IT effort through web browers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install. A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.

 

Nordic ePharma Day
8th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

At Nordic ePharma Day, the topic on the table is Risk-Based Monitoring the role of technology in supporting the transition from the “common” to the Risk Based Monitoring.

Centralized Monitoring has been proposed as a new, more efficient and cost‐effective approach to on‐site visits. A CSM approach performs data quality checks on all trial centers at the subject and site level. Statisticians can then analyze the data in real time to identify sites that need further investigation due to unusual data patterns. In a CSM strategy, many discrepancies can be improved by implementing cloud‐based technology solutions. Clinical Data Visualization and analytical business intelligence tools should be considered to query the EDC database and design reports for the main personnel involved in the trial review that assess site activity for quick analysis and decision‐making. Tools available today are generally cloud‐based which means Sponsors avoid the technology hassle of HTML or plug‐ins and enjoy the convenience of data “on the go”.

ARITHMOS is pleased to sponsor both of these Nordic Life Sciences events and promote the role of technology is these life sciences trends. If you are interested in attending these events, please visit the event websites. If you have a need for technology solutions in pharmacovigilance or Risk-Based Monitoring, please contact ARITHMOS for an RFP.

ARITHMOS Launches Survey on Pharmacovigilance Market & Challenges

In an effort to better understand the complicated, yet growing, pharmacovigilance market, ARITHMOS has launched a survey on present challenges facing pharmacovigilance professionals.

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This market survey aims to meet two key objectives:

– Understand the most pressing issues pharmacovigilance professionals face in terms of safety systems, inspection readiness and reporting
– Understand expectations in terms of financial investment in safety systems and what constitutes a good Return on Investment

The ARITHMOS pharmacovigilance survey is intended for market research purposes only and should take approximately 10-15 minutes to complete.

TAKE THE ARITHMOS PHARMACOVIGILANCE SURVEY