8 TECH OUTLOOKMarch - 2019IN MY OPINIONIndustrializing Operational Excellence through Quality, Innovation and ExpertiseBy Jinu Jose, Vice President, Operations, Cenduit Operational excellence (OpEx) is often described as a journey that organizations take to consistently improve the value of their offerings to clients, stakeholders/shareholders and employees. For eClinical technology providers, the ongoing journey must be hyper-focused on customer problem solving. Specialized global/localized project management teams should partner daily with sponsors and other eClinical stakeholders to work through some of the most crucial, data-driven challenges facing studies: highly variable demand cycles, further de-risking the business, and increasingly inexperienced interactive response technology (IRT) stakeholders.The technology provider's focus over the past several years has been on applying interventions driven by data, expert insights and in-depth analysis. Continuous improvement, problem solving and managed innovation need to be the DNA of the provider's teams, championed within every aspect of an organization.Why OpEx Matters Today More than Ever in Clinical TrialsClinical research, unlike other industries, has multiple dependencies and stakeholders, particularly across the regulatory spectrum. The extent of operational industrialization, especially with external stakeholders, has been limited to-date. However, opportunities to partner with the industry to drive further improvements for patients and sponsors is becoming more prevalent.With rapidly complex trial designs, regulatory scrutiny, and emerging drug development models, the need to continuously innovate remains a challenge. On the horizon, numerous innovations ­ including Artificial Intelligence (AI), machine learning, analytics, and robotic process automation ­ also are expected to disrupt various service delivery models through 2019 and beyond.We must remember that alongside the convergence of these trends in today's environment, OpEx is the lever for driving higher productivity/efficiency and quality, which results in better outcomes in clinical studies. How Industrializing OpEx Drives Quality Patient OutcomesAt its core, industrialization, rooted in the philosophy of the industrial revolution, focuses on the division of labor, economies of scale, and mechanization/automation to drive outcomes. Outcomes historically include reduced risk, better quality and efficiency, standardization, and improved turnaround times. In the services industry, industrialization simply means applying various interventions (process, technology, tools, practices) to ensure that we improve the predictability of service outcomes. Jinu Jose
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