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We can easily observe how far digitalization, data and connectivity have become part of our daily lives in all its dimensions. Accelerated in the “post-COVID era”, we experience this digital evolution when practicing sport, socializing, working, traveling, enjoying music or a good movie. Although this may sound like stating the obvious, it is important to be aware of this evolution, now integrated in the genome of new generations, and of its impact on health and clinical research.
Follow us on a “design fiction” approach, issued from a “design thinking” practice with an enhanced perspective of possible futures. Human imagination is often scoping the next big advances in society. We experience today concrete innovations which were once described as fiction a few years ago in literature, movies or even more recently in video game production. There are numerous references to reparable or digitally enhanced humans, capabilities of permanent and real time interactions, dematerialization and robots powered by artificial intelligence. Data, and our ability to make sense of them, materializes those potential futures, with the fast-growing use of connected wearables, bio-implants, digital twin patients, remote medical interventions and predictive diagnostics.
In this context what should therefore be the future of CROs in order to meet the needs of the Life Science industry as well as public health? How can they bring more value to treatment development in a future of advanced biologics or digital drugs?
The CROs of tomorrow should consider the inclusion of the most recent technological advances in their service offers to clients. Those innovations accelerate clinical development time while facing quickly expanding emerging diseases, manage complexity tackling stronger challenges (ie. oncology, neurology or rare diseases), and trigger the move from retrospective or interventional medicine to predictive and translational medicine. Another important consideration is the transition from classical medicine to data enhanced medicine, where data scientists and doctors are working jointly to improve patient health outcomes. We can envision a near future where most physicians will have data and translational science knowledge.
If we take a step back, the cornerstone to this evolution stands in a simple 4 letter word; “D.A.T.A.”. The CROs of tomorrow must, like the physicians of tomorrow, acquire the capability to handle life science and data with the same level of expertise. They will fully integrate both in their operations throughout the whole clinical development frame (phase I to IV) and through the whole spectrum of delivered services and practices. Finally, the new CROs must be digital and connected as well as strongly interfaced with innovative ecosystems.
This evolution starts by switching to a routine use of digital and mass data solutions used in clinical development management, such as systematic implementation of e-Data Collection (EDC), e-Trial Master Files (eTMF), e-Patient Reported Outcomes (ePRO), eConsent, e-Case Report Forms and the possibility to convert collected data to SDTM or CDISC formats.
Next comes the accelerators’ part; the innovations and disruptions catalyzing the progress of science. In this field, the ecosystem of startups and incubators developing health centered solutions leveraging new technologies is pivotal. The CROs of tomorrow will merge capabilities of new technologies applied to life science with clinical and regulatory expertise to effectively develop new treatments.
Below highlights just some of these latest innovations and their potential use cases; all constantly and exponentially growing as with technological advances.
Digital Twins: allowing to simulate in silico the mechanisms of actions and interactions of molecules or biologicals in virtual patients, supported by a complex and AI-supported modeling of physiology. The in-silico development is helping to screen faster new molecules and support de-risking of clinical development or reducing the size of the cohorts to be enrolled in clinical research.
Clinical Data Fabric: designed to capture data from clinical trials issued from different sources, based on data integration and data management. It allows global and real time access across an organization, capitalizing on historical clinical data and newly generated ones. All the data generated, or to be generated, become organized, accessible and available for research needs or transversal analysis.
Remote Monitoring: digital applications merged to handheld devices, for example a smartphone, used by health care professionals or patients to capture observed symptoms, analysis results, images or sounds. This way, monitoring becomes less intrusive in the patient’s life. It reduces the need to attend a health center, and it increases the amount of valuable parameters and related data that can be tracked.
Wearables: smartwatches, or specifically designed ones, to capture biological or physiological data in patients, with the capability to do it continuously and with minimal burden which can then be uploaded into a data cloud. Whether that be heart pulsations, body temperature, blood pressure or glucoses level, the list is constantly expanding.
Biomarkers: biological compounds naturally present in a patient, such as complex molecules or genes; these are indicators of specific physiological processes or diseases. The capability to capture mass data of those biomarkers from large populations and identify correlations with artificial intelligence tools in defined pathologies, like in oncology, to support faster development of new treatment. It could also allow definition of patient groups where the efficiency of a drug will be significantly higher or lower.
Predictive analytics: based on clinical and biological data from patients. Supported by machine learning technology, the interpretation of this data anticipates health conditions and provides insights to health care professionals and ultimately to patients to better manage or prevent potential risk. Here again, the application of this technology in clinical research will enhance development timelines, reduce cohort sizes and bring personalized insights to enrolled patients.
In conclusion, are the CROs of tomorrow becoming data companies? Are data companies the best positioned to become the CROs of tomorrow? The answer is NO. The CRO of tomorrow is a CRO that will smartly and efficiently include in its foundations, its practices, and its capabilities, the highest standards in merging classical CRO delivery with innovative data science enhancement. They will have to build a strong expertise in both dimensions, integrating data scientists and digital experts to forge their future and meet the needs and expectations of their clients, of public health and of the patients.
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