As the ways in which clinical trials are conducted and monitored continue to modernize at pace, there is an urgent need for digital transformation in the industry. If sponsors are to realize their goals of running flexible, decentralized trials (DCT), risk-based management (RBM), or adaptive trials while adopting big data, artificial intelligence / machine learning (AI/ML), the emphasis must now be on technology solutions that optimize clinical trial data workflows by bringing the technology to the data.
The end of inefficiency
As unprecedented challenges faced the industry in 2020, the world waited on accelerated clinical trials in the rush to find vaccines and therapeutics. With this drastic shift in priorities, non-essential drug development programs had to take a back seat. According to Global Data1, almost 1,000 trials continue to be disrupted today.
This emphasis on speed and progression enabled companies to realize that the current way of conducting clinical trials is neither efficient nor dynamic enough. It has resulted in a crucial shift towards greater digitalization and the adoption of new patient-site centric technologies and processes that focus on continuing patient safety.
The new reality revealed that the clinical technology platforms that have been adopted are far from ideal, as new solutions have been stitched onto already sub-performing legacy systems. The intricate patchwork of systems that many have ended up with (see Figure 1), was never designed to function holistically, preventing teams from having a ‘single-source of truth’ with actionable, up-to-date data.
What is urgently needed is a nimble and agile single technology platform that can enable all stakeholders to manage, explore, visualize and analyze clinical data effectively. To give full control from phase I to IV, the technology needs to effortlessly handle unstructured data, reduce the responsibility of site staff, and provide a complete view of the trial data with instant visibility.
Figure 1: A patchwork of clinical trial systems
Redesigning clinical trials
As the world shifted to a more digitized way of working, with virtual events and video calls becoming the norm, the clinical trial industry has been pushed to adopt new ways of operating, backed by new technologies. The increased adoption of virtual/decentralized trials brought forward the discussion of terms such as direct data capture, remote monitoring, and remote trial management.
With the volume and variety of data sources increasing (EHR/EMR, RWE, EDC, ePRO/eCOA, wearables, genomics and biomarkers, lab and CTMS2, to name but a few), it is now critical for anyone operating in the clinical trial space to have a defined data strategy, with internal teams such as data managers evolving towards data science, providing remote monitoring of trial data in real-time.
A sole, holistic platform to gather, evaluate, review, and visualize all trial data, should be a priority for sponsors on the road to digital transformation. When choosing a new eClinical system, they must take into consideration its purpose, how it will help manage complexity and streamline processes. Ultimately, the objective is still to increase data quality and maintain patient safety and regulatory compliance, whilst addressing the struggles that so many endured for so long – the pain around aggregating and integrating disparate data in trials, the perpetual data lag from capture to analysis, and the pervasive two-dimensional and poor-quality visualizations.
Enter encapsia
Unlike traditional systems, encapsia is built for purpose, leveraging modern concepts to revitalize clinical trials and giving users the experience of tech that they use in other aspects of their lives. It was designed to address the pain around remote collection, integration, and availability of disparate data. It offers powerful visualizations to provide greater oversight, down to the source data level, to allow immediate action and optimize trials.
Encapsia is the most innovative and powerful clinical trial technology platform on the market for collecting, managing, visualizing, and analyzing clinical trial data. This revolutionary eClinical solution leverages modern architecture to advance clinical trials, optimizing data workflows and removing the silos. Adopting encapsia makes real-time real, with all data available as soon as it is entered to give you up to the minute insights into trial progress that can help inform your clinical trial decisions, saving money and time whilst increasing patient engagement and site satisfaction.
Figure 2: Encapsia Insights: unrivalled oversight of data
Summary
The radical shift of organizations from the traditional, staid clinical development process through digital transformation has long been just a vision in the minds of clinical trial leaders but is now becoming a reality.
Implementing a technology like encapsia into their workflows will not only improve efficiency, support speed to market, but also cascade further through the company, increasing the effectiveness of clinical teams and reducing costs. The long-sought modernization clinical research can now be realized with true digital transformation.
1 GlobalData, (2021). Covid-19’s impact on clinical trials: GlobalData analysis at OCT West Coast. Retrieved 7 June 2021, from https://www.clinicaltrialsarena.com/analysis/covid-19s-impact-on-clinical-trials-oct-west-coast/
2 Electronic Health Record/Electronic Medical Record, Real-World Evidence, Electronic Data Capture, Electronic Patient-Reported Outcomes, Electronic Clinical Outcome Assessment, wearables, genomics and biomarkers, lab and Clinical Trial Management System
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