It is now imperative for life science companies to optimize Regulatory Affairs resources using next-generation technology if they are to ensure affordable patient access to treatments and achieve commercial viability, new independent research finds.

BOSTON, Nov. 12, 2024 /PRNewswire/ — ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today confirmed that while unsustainable workload increases have created an irrefutable urgency around advanced AI adoption in Regulatory Affairs (RA), many life sciences companies are standing in the way of their own progress. These are the findings of new independent research.

The study, conducted by Censuswide in September, is striking both in its confirmation of how vital AI-powered process change has become, and in its revelations about persistent barriers that are compromising companies’ regulatory transformations. That is as soaring workloads overwhelm already-overstretched teams.

ArisGlobal commissioned the exclusive survey of senior US regulatory professionals in pharma/biopharma companies to examine the growing appetite for AI within an RA context.

Key findings

BUT: outdated mindsets are standing in the way of progress

The survey identified a series of perceived barriers still holding RA departments back from investing or expanding their investments in AI, even where these are now unjustified, e.g.

Budget, on the other hand, is far less of an issue.

Confirming that companies’ perceptions have not kept up with AI’s progress, respondents said they would be more proactive about adopting AI in RA if:

AI is the future

Senior regulatory professionals DO see AI in their futures, meanwhile:

Commenting on the research findings, Ann-Marie Orange, ArisGlobal’s CIO and Global Head of R&D, said: “The pressure from regulators to drive up product quality and safety cannot be ignored, but nor can the drive to bring critical treatments and therapies to market more swiftly and cost-efficiently.

“It is why the industry must now double down on its adoption of AI, especially next-generation technologies such as Generative AI and machine learning. Up to now, life sciences companies have been standing in the way of their own progress, not appreciating what is already possible. But now the urgency to find step changes in process efficiency make it imperative to overcome those barriers and transform the way they work.”

Preeya Beczek, a respected regulatory consultant and founder and CEO of Beczek.COM, said: “AI is coming into its own in the life sciences regulatory space now, and companies ignore its potential at their peril. Think about it: R&D organizations must be both stringent in their regulatory compliance, and hyper-efficient in securing and maintaining marketing approval in order to get products to patients faster. That requires a gear shift which next-generation automation and AI can help deliver.”

The full survey report, The Imperative to Automate: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, will shortly be available to download from the ArisGlobal web site at https://www.arisglobal.com/. As well as a full analysis of the findings, the report includes practical recommendations on how life sciences regulatory functions can embrace AI capabilities today within their existing IT environments.

About the research

This report is based on an exclusive survey conducted for ArisGlobal by Censuswide between August 30 and September 06, 2024. The research was conducted among a sample of 100 US respondents in senior regulatory roles at pharma/biopharma companies.

About ArisGlobal

ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn or visit www.arisglobal.com. 

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