Regulatory workflow — the next digital pivot for pharma

September 6, 2022

Pharma is traditionally a conservative industry, but Covid-19 turned it on its ear. Industry leaders became acutely aware that their companies’ protocols, especially around regulatory workflows, slowed down their ability to introduce vaccines and medications in a swift timeframe. Consequently, the pharma industry now has an appetite to harness digital technology to shift cumbersome regulatory workflows into high gear.

In fact, Covid has triggered a change in life sciences investment to the tune of tens of billions of dollars – a large portion of which is earmarked for technology improvements, as evidenced through the billions spent on laboratories needed in the development of RNA vaccines which will be reused for future pharmaceutical development. This sizeable investment is expected to pay dividends for the next two to three decades as the standardisation of digital technology helps the industry overcome regulatory, organisational and other barriers.

During a recent DXC virtual event, 15 pharma industry practitioners responsible for meeting regulatory requirements participated in a short survey. Although the sample size is small, we believe the results do generally conform to overall industry-held beliefs based on discussions we have had with our customers and others in the sector. The respondents overwhelmingly agreed that regulatory workflows are primed to accelerate agility, flexibility and resiliency through digitisation. In fact, 80% of the respondents felt that more than 30% of the current regulatory workflow could already be successfully digitised. 

With pharma companies looking to quicken the development pace to develop and get drugs to market sooner, they need to get data from disparate sources faster to determine if everything is indeed on track. Digitisation helps aggregate data faster so that they get insights sooner and make needed adjustments sooner from drug trials, saving time and money. A key benefit for pharma through digitisation will be de-risking their portfolio and increasing successful go-to-market rates.

Barriers to embracing technology to improve regulatory workflow

Are pharma firms leaping at the opportunity to adopt technology that is increasingly ripe for the picking? Not necessarily. Here’s what we learned when we asked the professionals about the biggest barriers to digitisation at scale:

#1 – Complexity. A large majority (78%) said the biggest barrier is the vast array of internal processes and systems in pharma companies. Organisational and operational complexity hampers digitisation. 

#2 – Resourcing. Forty-four percent of the practitioners ranked lack of adequate resources as the biggest barrier. Covid triggered a massive turnover of experienced workers, and educational institutes are struggling to meet the demand in pharma and other industries. Indeed, only a handful of educational hubs actually converge medical sciences, business and technology streams, making the triple-threat digital resource needed within the industry a unicorn. One way to cover this gap would be for pharma companies to invest in technologists’ science and business education.

#3 – Compliance and eCTD adoption. While global use of electronic common technical documents (eCTD) is now in the double digits – with approximately 13 regulatory agencies accepting eCTD submissions – there is still an acute need to digitise processes in low-income countries. Efforts to align documentation across regions would go a long way to speeding up approval processes.

#4 – Lack of mature AI tools. Automating processes is key to improving the technology landscape for regulatory workflows. However, to make effective inroads in the pharma industry, automation needs to do more than simply replicate existing processes. Instead, companies need to look for innovative ways to revise the processes based on the ever-expanding technological capabilities, which begs for AI intervention.

Where do we start?

At DXC, we believe simplifying operations by deploying and maintaining a secure, streamlined and flexible enterprise IT landscape is essential for effective corporate change. We have partnered with AT&T, for instance, to help pharma and other companies forge a path to innovation through enhanced network performance, global coverage and scale.

At the product level, properly digitising the regulatory workflow can enhance productivity and amplify the user experience. Automating eCTD submissions and onboarding users through e-learning modules quickly accelerates process change. We have found that as you review processes and implement technology, it is crucial to involve all end users – making sure to include both direct and indirect stakeholders across the value chain. 

Identifying the prime workflow targets for digitisation can take many forms, from simply listening to end users to launching systematic investigations that unearth unstated needs or bottlenecks in performance and applications.  Prioritise first steps and identify pockets to tackle in subsequent waves. Then regularly identify new areas to digitise over time.  

We believe the time is ripe from both a technological and industry perspective for pharma companies to take advantage of digitisation and pivot to enabling faster and more efficient regulatory workflow.