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Capitalising on the pandemic’s lasting impact to enhance process efficiency

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As the life sciences sector grapples with a rapidly changing environment and increasing regulatory scrutiny, Frits Stulp of Iperion – a Deloitte business, predicts that by harnessing the power of digital transformation, companies will reduce process burdens to focus on delivering optimum patient outcomes.

Key insights:

Last year was another challenging one for the life sciences industry. On top of residual pandemic-related challenges and supply chain issues, the ever-adapting regulatory environment has continued to set new standards and enforce new requirements. Those companies that have managed to keep pace with the changes can expect to start reaping some of the rewards of their efforts over the coming year. Others still have work to do, but as new waves of digital transformation promise new process efficiency burdens should start to reduce and improved patient experiences will gradually become a reality.

Here's a roundup of some of the most notable developments of the last year, and what’s likely to be a growing focus in 2023.

Streamlining EU clinical trials

In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022, and the transition to the new registration system has begun in earnest now. From February this year, all new clinical trials applications must be submitted via the new portal yet a good many companies are not yet well set up for this, leaving work still to do.

The aim of the EU developments is to harmonise and streamline processes across the diverse region, making it a less daunting location for conducting clinical trials. Persistent anomalies between countries continue to trigger enquiries however, and this year all kinds of companies will be trying to figure out how to navigate the new requirements and overcome any residual complexity. This area also screams for further integration with related overall (master) data, such as related (active) substance, organisational info, and other product related information that is shared with the regulator.

Critical insights for public health

Supply chain issues, driven by the pandemic, continue to present problems - a situation that has been exacerbated during the winter, when demand has been at an all-time high. Even though the worst of the recent crisis appears to be over, there is now an extended mandate - certainly in Europe - to monitor and manage any shortages of medicinal products and medical devices. That’s both at an industry level, and by EU member states.

The onus is on the industry now, to capture and provide the right data during major events and public health emergencies. This may require formal data mapping – to identify where the relevant data sits within a company, and who can provide it. Given that efficiency and accuracy of these insights are critical when public health is at stake, it is essential that the industry is prepared. Forward-thinking companies will see this as an opportunity to review existing data governance, determining where the relevant data sits within their organisations, for instance, and how it might be provided to the EMA most efficiently.

The increased speed of regulatory processes seen during the pandemic has set a precedent, and the only way to maintain that pace over the longer term is to modernise. ISO IDMP standards remain pivotal to the expanding and transforming role of data – so that it becomes a lever for improvement. But this requires more proactive data governance, if companies are to truly harvest the power of their data.

Accelerating regulatory processes

Necessity being the mother of invention, much faster regulatory processes materialised during the pandemic - from rapid access to scientific advice and rolling reviews, to accelerated assessments and other possibilities under compassionate-use programmes. Improvements were also seen in the drug development process itself.

Ultimately, the pandemic forced out-of-the-box thinking and helped identify weaknesses in existing systems. We’ve seen old norms being challenged in clinical trials, for instance, as the result of issues that peaked in the pandemic, including those linked to subject recruitment. These issues have helped inspire alternative approaches to trials and their design - including decentralised trials, faster data sharing, and increased collaboration across parties.

The overriding challenge for this industry now will be to hold onto some of the great lessons of the last 2-3 years and use them as a springboard to reduce the time to patients of the latest advances in life sciences. As 2023 gets going in earnest, the real sign of commitment to a transformed future will be a passion not just to improve compliance and operational efficiency within and across life sciences stakeholders, but also to have an impact on the future of health.

As escalating cost and resourcing pressures threaten safe access to healthcare for all, the drive for new care models is strong - and data lies at the heart of many of the proposed solutions. These include increasingly sophisticated patient self-care propositions (using devices for condition monitoring and management), and selective first-line care provision by high-street pharmacies.

From operational efficiency, through more automated processes, to more convenient and affordable routine patient care, the unifying enabler is good quality, standards-based data that everyone can trust.

In specific terms, we can expect clinical trial innovation to continue apace; defined next steps toward IDMP implementation in the EU and US (beyond the immediate DADI-based Marketing Authorization submissions process); as well as further clarifications on ePI and serialisation.

Data-driven transformation of healthcare

While fine details may need to be determined in the data requirements for data-driven marketing authorisation applications, or clinical trial administration, there is no viable excuse for delaying transformation. Although there still remain many challenges and obstacles in the digital transformation of the life sciences sector, companies that blaze the trail to transformation have the potential to reap the benefits in the coming year. With the promise of improved efficiency, processes, and patient experiences, the data-driven transformation of healthcare is a vital step in providing better healthcare outcomes.

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