Accelerating R&D innovation in 2022 and beyond

R&D has been one of the last areas in life sciences to modernise and transform operations, but new strategies and technology have had a significant impact within clinical and regulatory.

Over the last year, life sciences companies settled into new operating models and remote ways of working because of COVID-19. Many have realised that returning to pre-pandemic days is no longer necessary as the shift to decentralised and digitally connected operations accelerates.

Next year, fueled by insights garnered from more robust data, companies will achieve new levels of efficiency that will drive patient-centered care. Here’s how Veeva envisions this playing out in 2022.

Patient and site centricity will drive the next phase of clinical trials

During the pandemic, the industry accelerated the adoption of decentralised trial capabilities to bring more trial elements directly to the patient. But predictions that life sciences would shift to a fully virtual model in which research sites become less relevant have already been proven wrong.

The industry is now moving toward a hybrid model of trial execution with some decentralised elements. As critical touchpoints for patient engagement and retention, sites (and investigators) will continue to play a vital role. With more clinical data being captured electronically, we’ll see faster trials that are better managed and speed delivery of new therapies.

Drug development will increasingly rely on a single, consistent source of data

As R&D teams work to reduce point solutions, many are realising the importance of data quality. For example, on the clinical side, patient data must be aggregated and cleaned if using new sources, such as wearables, to connect it with trial and clinical operations data. Companies that cannot do this will find it challenging to learn from past events to improve operations.

In 2022, we expect to see more companies adopt data management tools that will automate and speed up this work by ingesting, aggregating, and cleaning data so that it’s easier for clinical teams to analyse and share reliable information during study conduct.

Pharmacovigilance transformation will accelerate

R&D has been one of the last areas in life sciences to modernise and transform operations, but new strategies and technology have had a significant impact within clinical and regulatory. Pharmacovigilance is now catching up as more companies re-examine how they handle case intake and processing in parallel with their document management needs. Safety departments are now taking a proactive approach earlier in drug development and investigating more advanced technologies for signal detection, analysis, and management.

In the coming year, automating manual processes and finding new ways to process information will be crucial to improving patient safety and maintaining compliance. So will simplifying data management systems, their validation, and ongoing maintenance. As more organisations modernise pharmacovigilance operations, safety departments will focus on the opportunity to manage end-to-end processes and information more holistically, improving efficiency and compliance.

Authors:

Jim Reilly, Vice President, Vault R&D and Quality at Veeva System

Rik Van Mol, Senior Vice President, Development Cloud at Veeva System