What lies ahead for reporting and analytics in pharmacovigilance? Will it drive business innovation as patient safety transitions from a cost center to a strategic asset? A group of industry experts recently explored the significance of safety insights and areas conducive to organizational growth.
During the discourse, attention was drawn to Datacreds's SALVUS platform, which delves into the company’s commitment to extracting strategic insights from patient data. It empowers organizations with advanced analytics, fostering improved decision-making and heightened patient safety.
Essential Insights for Pharmacovigilance Teams
While case management teams are inundated with various reports, from monitoring to compliance, drowning in information isn't ideal. More data translates to more reports and increased bandwidth demands from dedicated pharmacovigilance professionals. Analytics in pharmacovigilance aim to streamline operations to meet regulatory standards and enhance patient safety and care. Efficiency is paramount, yet tapping into insights within the vast expanse of case data presents a challenge. It's crucial to discern which aspects of case management insights are pivotal for driving business innovations and improving patient outcomes.
The crux of the challenge lies in converting the escalating volume of data into actionable insights. What insights from a case management perspective are most likely to foster business innovations and bolster patient safety?
When data is relayed to regulatory agencies such as the European Medicines Agency (EMA) or the United States Food and Drug Administration (FDA), case management monitors scrutinize patterns within the data. Are there any causes for concern? Should further investigation be conducted? The key is a system's ability to flag anomalies in patient data patterns, eliminating the need for human review of every report and signal. Automated alerts empower pharmacovigilance professionals to focus on pertinent data, rather than wading through an avalanche of reports. Whether it's lingering cases or additional submissions from different regions, a tool that alerts to inconsistencies enables teams to nip issues in the bud.
An analogy can be drawn to the concept of digital twin analysis, which involves comparing actual workflow data and compliance data with a digital twin representation. Deviations in the digital twin or prolonged cases in the workflow trigger alerts. Lingering cases may signal vendor-related issues, underscoring the importance of early detection.
Preparing for the Future of Pharmacovigilance
Harnessing automation across safety workflows enables professionals to dedicate more time to value-added activities. Systems should facilitate easy access to insights and amalgamate various data sources for quicker time-to-insight. While advancements in artificial intelligence are pivotal, there are opportunities to enhance productivity by tapping into human intellect and implementing rules and data integration.
Apart from liberating human resources, the future of reporting and analytics encompasses strategic elements. Systems should facilitate proactive decision-making by learning and aiding in crafting predictive and proactive measures. Gathering extensive data, including qualifiers and quantifiers, can pave the way for predictive analytics. For instance, analyzing the impact of company holidays on compliance may necessitate constructing knowledge graphs to decipher relationships between various factors.
In terms of system design, embedding more intelligence to detect errors before advancing to the next workflow step would be advantageous. It's imperative to ensure seamless information flow between different departments and avoid IT-centric analytics activities. Empowering users to derive insights from machine learning algorithms within analytical tools is beneficial.
The ideal scenario entails sharing data among various departments, such as epidemiology, pharmacogenomics, pharmacovigilance, and clinical, in a unified repository. Currently, pharmacovigilance data is scattered across multiple silos, leading to fragmented reporting processes. A unified interface that integrates data from different modules and facilitates visualization through charts and graphs would be invaluable. Reducing the number of steps and transitions between data silos can markedly enhance efficiency and promote clearer data coexistence. Aligning with the SALVUS MultiVigilance safety database, the source of truth, is highly advantageous.
Prioritizing performance concerns and addressing data storage segregation is imperative. Understanding the rationale behind data separation and evaluating its impact on performance and availability is crucial. Integrating disparate databases and achieving better reporting performance while upholding transactional integrity is a complex undertaking that warrants careful consideration.
To surmount these challenges, Datacreds is integrating cutting-edge technologies into its products. The objective is to establish a unified repository for all data, aligning with the prevailing trend of platform-based solutions. This endeavor aims to cater to users' needs and expectations, enhancing performance and facilitating more efficient data analysis and reporting.
Comments