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.

 

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Pharmacovigilance Best Practices Part II: Consortium Initiative

In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams.

Two hands touch screen of tablet with medical icons. VectorIn order to facilitate the implementation, production and maintenance phases of a pharmacovigilance system migration project, ARITHMOS has introduced a consortium for the provision of Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of lower costs 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.

The concept of sharing implementation activities guarantees at least a 20% reduction in costs for Consortium subscribers. The benefits to joining are:

  • Access to experienced Project/Account Manager during set-up and production
  • Get a standard configuration built on best standard practices and experience
  • Have the PhV application hosted in a certified Data Center with backup/recovery processes in place
  • Compliance and regulatory expertise and support during inspections
  • Use of International Standards (GAMP5) and Internal QMS
  • Multidisciplinary team covering all validation aspects (Business analysts, IT experts, CSV specialists)

Why is the Consortium an ideal solution for pharmacovigilance departments?

Step 1: Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. It is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Business Processing Services (BPS) provider, ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee.

Step 2: The Consortium initiative also covers compliance and Computer System Validation aspects of pharmacovigilance through a Quality by Design approach. As a member of the Consortium, a cross-functional team of validation experts are available to make sure the system is maintained properly through periodic review and change control.

Consortium ROI: Consortium membership guarantees cost reduction through the sharing of implementation activities and documentation. However, the real Return on Investment comes from access to validation experts, advice and feedback from other Consortium members and access to “My Oracle”, which is Oracle’s official web portal for the support of its applications – guaranteeing a smooth, compliant and risk free pharmacovigilance process.

The Consortium is a yearly initiative with limited subscriptions available. For more information on a pharmacovigilance system migration project and Consortium membership, contact ARITHMOS at info@arithmostech.com.

 

 

 

Choosing an Efficient Pharmacovigilance System: the Critical Factors

photodune-2386650-human-lungs-in-digital-design-mPharmacovigilance is becoming a more pressing issue in drug and device life cycle, mostly due to increased regulations by the EMA and FDA 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 looks at the critical factors companies must consider when choosing a pharmacovigilance database and reporting system.

Is the system compliant with regulatory standards?

Is your company developing drugs or devices in the EMA? FDA? Or in the global market?

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 released good pharmacovigilance practice guidelines (GVP) which focus on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

Your pharmacovigilance system should be an up-to-date version that is validated and meets the requirements of computerized systems in the GCP environment.

Does the system have technologically advanced reporting tools?

Your pharmacovigilance system should have real-time reporting features in order to analyze safety data immediately.

  • Does the system have expedited reports for drug and device?
  • Does the system have detailed reports and dashboards to analyze workflow?
  • Does the system have support for ad hoc querying and reporting?
  • Can the system generate reports for case reconciliation?
  • Can the system report discrepancies between safety and clinical systems?
  • Can report data be extracted and distributed?
  • Can the system be integrated with other Business Intelligence reporting tools?

Is the system intuitive?

While the system itself may be complex in design, Pharmacovigilance Officers and Drug Safety Officers need to be able to use the system easily. Make sure the system has support for your pharmacovigilance workflow, case processing, case submission and reporting. Be sure your system provider has a HelpDesk service available for the more complicated functions.

Is the system available in the cloud?

The benefit to having your pharmacovigilance system offered as  Software as a Service (SaaS) is that it minimizes the IT effort and is easily accessible via web browser. 

Does the system have the appropriate coding functions?

In addition to supporting MedDRA and WhoDrug coding dictionaries, your pharmacovigilance system should have the ability to code all relevant data elements on a single screen.

Who will take care of the hosting, validation and maintenance?

When implementing a life sciences application like a pharmacovigilance database and reporting system, it is best to rely on technology experts. They can provide an analysis of user requirements and provide installation, configuration, validation and system maintenance in accordance with regulatory and ICT guidelines. 

The ARITHMOS Solution

argus safetyARITHMOS can implement a pharmacovigilance system as Software as a Service (Saas) with a standard validation configuration and customization applied to meet customer business processes and needs and ensure safety and comply with pharmacovigilance regulations.

As an Oracle Gold Partner, ARITHMOS can offer the Oracle Argus Safety Version 7 pharmacovigilance system, which is a native SaaS solution accessible via web browser. Argus is an ideal solution for managing a global workflow while providing case reports and instant safety data reports and analysis. The key functionalities are its easy-to-use interface, its system management, coding functionalities and reporting tools.

ARITHMOS can also migrate safety data from older, outdated and discontinued systems. 

Pharmacovigilance Day Germany – 2 April 2014 in Munich

ARITHMOS is sponsoring the first annual Pharmacovigilance Day – Germany edition which takes place on Wednesday, 2nd of April 2014 in Munich, Germany. The title of the event is “Designing an efficient Pharmacovigilance System: Integrating electronic systems to achieve an effective Safety System” and will highlight how the use of electronic systems can help companies achieve the appropriate safety system required by regulations, especially under the new GVP guidelines.

 For additional information or to register, visit the official event website