In 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.
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.