Frits Stulp of Iperion, a Deloitte business, predicts that a wave of data-driven transformation that began in 2022 will enhance insights and decision-making, allowing life sciences companies to gain a competitive edge and provide better patient experiences.

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.

Streamline Processes Across the EU

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 trial 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 inquiries, 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.

Data Governance is Key

Supply chain issues, driven by the pandemic, continue to present problems – a situation that has been exacerbated during the winter, when the 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.