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.