In just a couple of decades, information technology has undergone a radical transformation –a sweeping evolution from floppy drives to data warehouses to data lakes. Our industry has unfortunately not ridden the arc of technology at the pace of other industries. This has unfortunately left us flat footed when an epochal event, a global pandemic, struck in 2020. So now the moment is upon us to be bold.
We don’t have all the answers, but we do have some revolutionary technology on the market. Forward- thinking life science companies are defining their vision and looking for like-minded partners to execute it.
The good news is that for the larger, more mature organizations, the foundations are in place. By implementing a critical analysis of their current state – systems, processes, resourcing, development pipeline and use – combined with their experience, they are able to select best-fit solutions to adopt, adapt, and implement. Frankly, they are the experts on what this transformed clinical data enterprise becomes.
But where does this leave the larger portion of the clinical development industry, the small and mid-sized biotech, pharma, and medical device companies? They have neither the bandwidth nor financial stomach for grandiose tech initiatives. For them it’s always go time and they need to identify partners who can enable their data transformation with a holistic platform that does the heavy lifting, addresses the core needs of aggregating, integrating, and interrogating their clinical data in real-time.
Beyond EDC, more than 70% of clinical trial data lies outside of the study database. The volume and variety of data sources is only increasing – EHR/EMR, RWE, ePRO/eCOA, wearables, genomics and biomarkers labs, imaging and CTMS to name a few. It’s critical to have a defined data strategy and improve efficiency, but also to identify the right technology that sponsors can rely on throughout their clinical development.
The choice of data technology must be holistic, purpose-built, with a primary aim of removing complexity, reducing data friction and silos, and streamlining processes. The right solutions will have functionality that is easy to access and adaptable. Sponsors will then realize the benefits that come from immediate visibility of all the currently disparate data. In addition, such an end-to-end platform must support integrations to other systems, robust workflows, and the capabilities to enable cross-functional utilization by clinical operations, safety, data, and site users.
Small or mid-size organizations need not be left behind. Advanced, holistic data technology now empowers these types of sponsors for their virtual or decentralized clinical trials. Further, maximizing use of analytics and AI/ML, the trials of tomorrow will increase job satisfaction and study quality, reduce patient burden, and improve efficiency boosting speed to market and allowing clinical research teams to join the digital revolution so many other sectors have already realized.
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