Pharmacovigilance 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
ARITHMOS 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