September 13, 2018
Intelligent Automation: Exploring the next evolution of life sciences regulatory
By: Heather McIntire

The life sciences research and development (R&D) landscape has been experiencing a digital evolution; however, regulatory organizations have lagged behind. Technological advances, evolving user experiences and more stringent Health Authority expectations around data availability, consistency and compliance are driving this change, with no sign of slowing down. Intelligent automation—automation powered by artificial intelligence (AI)—offers regulatory organizations the opportunity to make significant strides in digitalization, and to transform the management and execution of regulatory processes.

Technology is advancing rapidly, and today’s consumers and employees expect more
How we interact with technology in our daily lives has changed dramatically over the past few years. Technological innovations lead us to expect convenience and personalized experiences in all aspects of our life—including at work. We want processes at work to be as intuitive as our smartphones, and we want to be able to access what we need with the tap of a screen.

While regulatory organizations have been somewhat overlooked in terms of R&D digital transformation, many organizations are starting to explore emerging technologies, in part due to cost and global compliance pressures. At Accenture Life Sciences, we see increased interest in AI and expect that it will become an essential enabler of productivity, innovation and speed to market for life sciences regulatory functions.

Improvements in computing power and AI technologies are making these advances possible, enabling processes around managing product drug lifecycles, for example, to be automated. Automation is advancing from tactical, rule-based robotic process automation (RPA) to strategic, judgment-based machine learning, broadening its application and opening new doors for organizations.

Artificial intelligence and automation: what’s possible
Life sciences regulatory organizations must find ways to operate more efficiently while supporting increasingly complex product development pipelines, requiring more active and ongoing engagement with Health Authorities. Existing resources are strained, especially as legacy IT systems become outdated and unsupported. Intelligent IT solutions can help organizations cost-effectively innovate their processes and operations. And as new technologies are introduced, more becomes possible.

High volume, routine and rule-based activities are easy targets for robotic process automation (RPA). More complex processes requiring judgment-based decisions and/ or use of unstructured data require more sophisticated technologies. Examples of commonly used artificial intelligence technologies are natural language processing (NLP), machine learning (ML), optical character recognition (OCR) and computer vision. Often these technologies are combined to achieve a desired business outcome.

Accenture is exploring these artificial intelligence technologies—and others—to demonstrate how they can be applied to the regulatory process. We are piloting automated activities such as data entry to create RIM submission events and the processing of health authority correspondences. We estimate improved compliance and data accuracy with the introduction of automation, along with significant time savings that can free up regulatory professionals to focus on the strategic aspects of their jobs—ultimately bringing more value to their organizations.

Moving forward
Life sciences R&D organizations should approach these new capabilities with a holistic strategy that aligns all functions, including regulatory—beginning with a long-term vision for transformation and leading with business outcomes that are aligned across the organization. Regulatory leaders will also need to ensure the right resources exist to implement the vision to reach those desired outcomes. To do this, silos must be broken down. IT and business must collaborate, involving the right stakeholders to maintain focus and drive change.

This convergence of advanced technologies, AI and robotics, volumes of data, and high expectations for speed to market and compliance are all driving the investment and transformation of life sciences regulatory organizations. There has never been a more interesting and exciting time to be involved in driving toward new horizons for the life sciences regulatory function.

I’ll be presenting on the exciting new possibilities in this area at the 2018 Veeva R&D Summit, which will be attended by more than 1,300 life sciences leaders and experts sharing best practices and industry trends. Come and see me there or connect with me on LinkedIn to learn more about intelligent solutions in life sciences R&D.

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