Here we share our predictions for the Industry Trends to Watch in 2024, offering our insights into the hot topics that will be shaping the drug safety industry over the coming year.
1. Automation, automation, automation
2024 will continue to see a focus on reducing time and resource-intensive activities within vigilance management processes, including a drive to better harness efficiency gains from automation and digitisation. From speeding up data entry and boosting the efficiency of case processing to improving quality of output, introducing a greater degree of smart process automation will increasingly be the goal for many organisations who operate pharmacovigilance departments.
2. AI makes practical inroads
The potentially transformative role of AI in PV has undoubtedly been the primary talking point on the industry event stages this year. Discussion of Large Language Models (LLM) and Generative AI (Gen AI) has dominated the conference agendas. With ever-increasing volumes of data to analyse and process in the performance of the PV function, the application of AI and machine learning capabilities clearly shows exciting promise. Positive impacts from this technology can easily be foreseen in areas such as automation of case intake and processing, improved signal detection and the identification and prediction of patterns, as well as in delivering richer safety insights gleaned from multiple data sources.
At AB Cube, we see the obvious potential of AI for boosting efficiency, reducing required resources and lessening cumbersome manual effort. To provide our SafetyEasy® customers with the earliest access to these advanced technologies, we’ve recently innovated CasEasy AI – an AI-driven solution for case entry and processing that provides auto-population of cases fields (such as adverse event, products, lab tests and so on), plus automated quality checking. CasEasy AI is the newest addition to our SafetyEasy galaxy, which now spans business intelligence, connectivity and automation solutions as “satellites” to our core SafetyEasy platform for fast, efficient and scalable compliance.
3. Data tells its own story
With the exponential growth in data sources – including real-time inputs – only set to accelerate, graphical data storytelling and data visualisation will be a rising trend in PV. Data visualisation can play a pivotal role in helping to improve and scale the evaluation of key data points – supporting integral processes from business intelligence and intake to literature management. SafetyEasy customers can expect to see data storytelling capabilities increasingly reflected in our platform, as we continuously innovate next-generation solutions to help customers more effectively leverage Big Data and analytics for vigilance management.
4. Opening up innovation
Open standards and connectivity to other business-critical internal systems that clients operate will be a major story in 2024. Recognising our clients’ need to innovate within an open and agile ecosystem of interoperable solutions, AB Cube is the only safety database vendor to have opened up our API, with our new SafetyEasy Connect functionality. Offering 9 endpoints – from case creation, data retrieval and updates to full product dictionary management – and harnessing OAuth 2.0 authentication, our API is now available in three licensing options: Case creation/update API, Connection to SafetyEasy data API, and Product Dictionary Management API.
5. Best of both worlds with private cloud
When AB Cube was founded in 2006, on-premise safety software was the industry norm. Back then, we had the vision to identify an opportunity to revolutionise the life sciences industry with the very first cloud-based vigilance solution. As an early pioneer of SaaS vigilance software, we’re now in pole position to enable the next industry step-change – towards private cloud solutions.
A multi-tenant solution with a single private tenant database is now the preferred option for many customers who are focused on data integrity and security. The widespread availability of on-demand cloud computing platforms such as Amazon Web Services means that private cloud solutions can now be offered at highly competitive price-points, opening up this capability to more and more clients who are looking to benefit from best-in-class software and architecture hosted on their own dedicated servers.
6. Global regulations continue to evolve
A big change set to impact regulatory compliance processes for global organisations next year is the US FDA’s expected transition to the International Council for Harmonisation (ICH) E2B(R3) format for electronic transmission of safety reports.
With our commitment to fulfilling regulatory compliance across all major geographies, AB Cube is ready and here to help our international customers navigate the challenges and complexities of the rapidly evolving global regulatory landscape. 2024 will also see SafetyEasy Suite add South Korea to its portfolio of supported countries, with more key regions due to be incorporated in 2025.
Here’s to a successful 2024!