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.



Why support more than one RDBMS (Relational DataBase Management System)?

The question should be obvious: why do I need to implement many lines of code and spend a lot of time supporting more than one database simultaneously?

In this blog post, ARITHMOS‘ Software Development Manager, Gaetano Giusto, discusses how you can support multiple RDBMS systems to control information storage and why you should invest the time and resources in doing so.


There are several answers to this question and are all correct in their own way. Obviously the main focus is to reach the most number of customers as possible and obtain the highest revenue selling your application. Nowadays there are several Operating Systems and a wide range of environments to support so you have to choose which one best fits your target customers’ needs.

It is difficult to say which is the best solution to develop because there are too many factors to consider and every situation is unique. The first thing to consider is that if you develop a solution which could support multiple applications such as Oracle, Ms SQL and MySQL alternatively, it could become really complex and require a lot of time in the analysis.

The second critical factor is the limitation you can encounter in supporting more than on RDBMS. In fact, not all RDBMS have the same performance level or the same enhancements, so you can probably assume the loss of some features that could be very useful.

Another thing to consider is that you need to develop more classes or a lot of code, and this could be frustrating if you consider that you have to fix bugs and develop specific functions for each RDBMS every time each vendor does some modifications.

If you can’t dedicate the time and resources to developing an in-house solution, you can think about an ORM – Object-Relational Mapping. This is a programming technique for converting data between incompatible systems in object-oriented programming languages.


ORM products (NHibernate, ADOEF), are well-tested before being released on the market. After all, these companies have a reputation to maintain, so you don’t have to worry too much about bugs. The chance of there being a bug in one of these frameworks is lower than any developer unwittingly creating a bug in his own data layer.

In conclusion, developing a solution that can support more than one RDBMS is quite difficult and requires more time and resources with respect to a single RDBMS solution. However, the most important factor to take into consideration is the market in which you operate. This solution can also help you reach a wider range of customers in order to sell your application, assuming you want to sell it. 

ARITHMOS Solution – Implementation of Applications

ARITHMOS Business Analysts support the key users in the definition of Business Requirements. During this phase, the key users are trained in the functionalities and standard workflow of the new system. In most cases, the user’s knowledge is limited to sales and pre-sales presentations, making a Business Analyst essential in this initial phase.

By using this approach, key users can deepen their understanding of how the system works and if it fits their organizational structure, proceseses and procedures. They can then define, together with the Business Analyst and technical experts, how the system should be configured. Knowing the system in the initial phase can reduce timelines and risks related to the operational target phase. Users who are trained and informed on the system adopt a proactive approach throughout the system implementation and qualification process.

Why Consider a BPS Approach for Life Science Technologies?


BPS – or Business Process Services – is an outsourcing strategy in which companies engage in licensing contracts with a third party vendor for back-office functions such as finance or front-office activities such as customer-related services. ARITHMOS became an Oracle BPS partner in 2011 and explains why the BPS approach in life sciences can be beneficial for companies.

A BPS strategy can take a lot of pressure of a company who wants to concentrate on its core operations activities and not deal with the task of maintaining an IT infrastructure. With more companies, especially in life sciences, using complicated database and reporting systems and cloud-based technologies, they must consider computer system compliance and various regulations. All of these factors can distract companies from their day-to-day operations.

What are the various advantages to a BPS strategy?

1.       Access to Experts in IT Infrastructure: Relying on a third party supplier with expertise in implementing, maintaining and validating systems takes the burden off the company. Expert IT analysts will perform an initial analysis to define user requirements which can reduce time and costs in the implementation phase and increase efficiency in the configuration phase.

Leaving technology activities to the experts allows the company to allocate more time to their business tasks.

2.       Focus on your Business Growth Strategy, Not IT Investment: IT investment for a company involves a significant financial investment, the hiring of more resources, more time allocated to maintaining the system including keeping with regulatory requirements and many, many training hours. In a BPS strategy, the IT experts and engineers worry about streamlining business processes and maintaining IT systems, while the company can focus on business strategy.

 3.       Cost Savings: If finances are a priority, BPS could be an ideal solution. Rather than investing in new technology and in new manpower, companies rely on the third party vendor, who is already streamlining processes and engaging in best practices for other companies. Oracle estimates that with a BPS strategy, cost savings could be between 15-35%.

Benefits of BPS include lower TCO (total cost of ownership) as well as operational costs since BPS looks to streamline administrative activities like payroll and human resource management while linking applications to any IT platform.

ARITHMOS BPS in Life Sciences

img%20per%20sito173116The joint value between ARITHMOS and Oracle exists in ARITHMOS having the capability to use and understand the Oracle applications and offer an optimum value package to clients. In turn, Oracle is providing ARITHMOS with a trustworthy brand and application to enhance the ARITHMOS business strategy through new product offerings.

By partnering with Oracle BPS, ARITHMOS offers its clients:

– Increased business efficiency and productivity with a reputable technology infrastructure
– Reliability through an experienced IT team to consult and manage business needs
– Capability to measure and quantify business efficiency inputs

Visit our website or email us at if you are interested in learning more about the BPS approach from one of our IT and business analyst experts.

Leveraging Cloud Technology in Pharmacovigilance

healthcare-cloudThis month ARITHMOS hosted its first Pharmacovigilance Day seminar in Milan, Italy. The event focused on modern technology solutions to meet the challenges of pharmacovigilance and collecting patient safety data. Gianluigi Albertini of Arithmos gave a presentation on the cloud computing technology as a solution for pharmacovigilance and discussed how leveraging cloud computing can be an effective and cost-effective solution.

The National Institute of Standards Technology (NIST) defines cloud computing as follows: “Cloud Computing is a model on-demand network access to a shared pool of configurable computing resources (e.g. networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction”.

As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications, maintaining and updating applications or disaster recovery. Resources can be assigned and configured to meet customer usage requirements in terms of functionalities and computer needs. In terms of resource optimization, business investment is better aligned with the service and guarantees a better Return on Investment (ROI).

In terms of time, cloud computing minimizes the time to delivery. Customers should be independent of the service provider in terms of application management which reduces maintenance time.

Pharmacovigilance Systems in the Cloud

edc1Pharmacovigilance applications should be accessed through the internet with minimal IT effort through web browsers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install.

To implement a cloud-based pharmacovigilance system, the application is deployed with a standard validation configuration with changes being applied to meet customer business processes and needs. The changes can be tested before the application is released into production.

Examples of pharmacovigilance systems in the cloud are Oracle AERS and Oracle Argus. Oracle AERS is a cost-effective and ready-to-use solution for managing Adverse Events from capture to reporting. Oracle Argus is a more comprehensive system with configurable workflow, advanced query and reporting functionalities, case import/export and document management.

However, Oracle AERS is not a Software as a Service (SaaS) system. It was developed to be used by personnel within the company LAN. External users cannot connect via VPN to the LAN, and the VPN is not always a stable connection. The best solution would be to publish AERS in Citrix with the plugin installation in order to reduce bandwidth usage.

Oracle Argus, on the other hand, is a native SaaS solution which can be accessed via web browser. After configuration and release, customers can use the application with minimal interaction using the service provider for maintenance.

Oracle AERS has been configured and validated according to a standard pharmacovigilance workflow. Reduced configuration and testing activities accelerate the system deployment with a cost-effective solution, and hosting and maintenance are regularly performed. Regardless of the system used, AERS or Argus, customized reports can be added to the default reporting capabilities of the application. Reports are created by the service provider and accessed via web portals from anywhere.

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.

ARITHMOS Hosts Successful Pharmacovigilance Day Seminar in Milan

arithmosOn the 12th of November, ARITHMOS hosted the first annual Pharmacovigilance Day seminar at Hotel Melia in Milan, Italy. The event, supported by Oracle Corporation, was born to discuss changes taking place in the pharmacovigilance environment, including new and and updated legislation by the European Union, and to present new and improved technology solutions to enhance pharmacovigilance management.

ARITHMOS put together a team of expert panel speakers to discuss pharmacovigilance safety databases, data migration, signal detection and regulatory compliance for pharmaceutical, biotechnology and medical device companies as well as CROs of any size. The reality is that many companies, especially of small to mid-size dimension, struggle to implement effective pharmacovigilance processes that both comply with regulations and improve efficiency while keeping costs under control.

Paolo Morelli, ARITHMOS CEO, introduced and moderated the event.

Panel speakers Robbert Van Manen of Oracle and Mike Roberts of Pink Octopus Consulting addressed new pharmacovigilance legislation. Robbert presented the EU’s GVP Module IX on Signal Management and how its requirements can be met with the current release of Oracle Empirica Signal and Topics. Meanwhile, Mike discussed the migration of a pharmacovigilance system to Argus Safety in order to comply with international regulatory standards, improve quality and data standards and positively impact productivity.

Marco Bulleri, representing Abiogen Pharma S.p.A., presented a case study on implementing an Oracle BPO (Business Process Outsourcing) solution for small to mid-size pharmaceutical companies. The case study demonstrated how Abiogen utilized this solution for the collection of safety data coming from both clinical trials and post-market surveillance and the support received by ARITHMOS in migrating and implementing the new AERS system.

healthcare-cloudRounding out the expert panel was the team of Gianluigi Albertini and Stefano Piccoli of ARITHMOS who did presentations on cloud technology. The presentations captured both a solution for pharmacovigilance and the adoption of technology trends in the healthcare field. Starting from the definition of “cloud” and SaaS (Software as a Service), Gianluigi demonstrated how current PhV systems such as Oracle AERS and Argus can be delivered as a SaaS solution. In the second presentation, Stefano covered compliance in the cloud including computer system validation solutions.

The seminar, which was conducted in dual language (Italian and English) and free for participants, received positive feedback from all attendees. Overall, participants found the seminar informative and useful for current pharmacovigilance needs and appreciated the chance to discuss and debate these issues in a professional environment.

The event concluded with a cocktail reception offered by ARITHMOS for all attendees.

ARITHMOS is planning to hold the event again in 2014 and add additional seminars on healthcare technology topics.

What do you think are the most relevant needs that should be addressed by health science technology? Answer our survey

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.

integration ePRO and EDC


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

Arithmos Experience

ipad clinical

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.

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