Pharmacovigilance is a vital part of the development of the new medicinal products. It makes sure that these products benefit the health of patients worldwide in safe and effective manner. With the increasingly stringent regulations and growing importance of patient centricity, pharmacovigilance plays now a much more central role than 10 or 20 years ago.
In this blog, our expert pharmacovigilance team is looking at the current industry trends in pharmacovigilance.
Outsourcing to Drive Operational Efficiency
Specialised outsourcing in pharmacovigilance is becoming a widely used approach to coping with the growing costs of maintaining a highly qualified and trained pharmacovigilance team in-house.
For Manufacturers and Sponsors, a well-implemented pharmacovigilance outsourcing program brings noticeable benefits including:
- Reduced fixed costs;
- Increased flexibility;
- Better outcomes in the short- and long-term;
Nowadays more and more companies are outsourcing their pharmacovigilance tasks to achieve better regulatory compliance, higher quality, better productivity, and improved strategic decisions.
Secondary Data Sources That Contribute to Early Detection of Safety Concerns
In the last years, the number of secondary data sources has been growing continuously and currently includes:
- Social media;
- Clinical data and electronic health records;
- Claims files;
- Regulatory reports and filings from different areas;
Secondary data sources present unique challenges in terms of acquisition and integration with “classic” data sets. Usage of secondary data by pharmaceuticals is, as of today, just at the initial stage considering also that it is not required from the regulatory point of view. However, projects like FDA’s Sentinel Initiative and EMA’s WEB-RADR show interest that regulatory agencies have towards the use of secondary data.
Recently, technology providers have started offering robust and flexible platforms that help Life Sciences companies handle and integrate a wide range of file types and incorporate social media streams in their pharmacovigilance processes. Advanced algorithms and disproportionality analysis are already being expanded to include not only classical spontaneous reporting, but also social media streams.
The secondary data sources together with advanced signal detection technologies help early detection of safety risks and allow to take risk minimisation measures more rapidly.
Cloud-based Reporting to Bring a Robust Global Database of Adverse Events
Many industries are now benefiting from the ability to store and analyse huge amounts of data in the cloud. As the number of data sources grow, Life Sciences companies face the urgent need to optimise the intake, storage and analysis of big volumes of data.
Among the main drivers for moving into the cloud are:
- Cost and efficiency: cloud could allow companies to work with a big amount of data from cases without compromising quality, security and data privacy;
- Scalability: the adverse event case workload for Life Science companies has been rising steadily, with some companies seeing a 50% increase yearly. This rise calls for technology that can quickly accommodate the growing volume of data;
- Simplicity: cloud usage can simplify the life of companies by allowing them to avoid concerns about module compatibility and scaling up servers.
Cloud in pharmacovigilance is becoming the reality. In the recent survey conducted by Oracle, 60% respondents either has some or all of their safety solutions in the cloud or are planning to move there within the next two years.
Big Data to Protect and Assimilate Huge Amount of Information
Recently novel sources of real-world evidence and experimental data in digital form have become available also to pharmacovigilance professionals.
In pharmacovigilance, big data include such sources as:
- Signal detection;
- Substantiation and validation of drug or vaccine safety signals;
- Online channels and social media.
Due to its complexity, big data represent both an opportunity and challenge. With support of technology solutions with advanced computing capabilities, Life Sciences companies use big data to monitor and study drug safety in a more effective manner.
Data Analytics to Drive Actionable Insights
The effective management of safety data stored across multiple platforms is vital for clear understanding of safety events. The growing number of Life Sciences companies turn to advanced analytic techniques in pharmacovigilance to examine large and varied data sets that contain safety information. They strive to uncover new patterns, unknown correlations, trends, and patient preferences that help them to ensure patients’ safety more effectively.
Nowadays, pharmacovigilance analytics provides a real opportunity to harness data effectively, ensure regulatory compliance and drive actionable insights.
Automation for Non-value-adding Tasks in the Pharmacovigilance Processes
Life Sciences companies are actively looking for ways to reduce the growing pharmacovigilance costs and lower the possibility of human errors in pharmacovigilance tasks. Automation is a vital element that can help businesses to achieve both goals through:
- Making end-to-end safety processes leaner;
- Eliminating redundant steps in existing processes;
- Boosting team’s efficiency;
As regulatory bodies introduce new tools to collect and evaluate adverse events, Life Sciences companies get more and more possibilities to integrate automation in their everyday pharmacovigilance processes.
How Can seQure Support You with Pharmacovigilance?
Our pharmacovigilance team boasts more than 25 years of experience. We offer to our customers a complete portfolio of drug/medical device safety and risk management services for the collection, monitoring, assessment and analysis of safety information and the detection of new safety concerns.
We leverage our decades-long experience and expertise to maximise your product potential whilst ensuring patient safety. Are you looking for support with your pharmacovigilance operations?