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SELECT LANGUAGE:
We admit it, we were wrong. Many of us, including the scientific community, were not ony hoping but expecting the COVID-19 pandemic to be over by now. In April of 2020, University of Minnesota experts estimated 18 to 24 months of pandemic, meaning we’d currently be at the tail end, not seeing spikes like the ones in Mainland China and Hong Kong. A month after that research was released, WHO expert Maria Van Kerkhove said she had anticipated the acuteness of the pandemic to have peaked already—months before the Omicron variant appeared.
At first, the pandemic and related restrictions paused certain work in the life sciences industry as travel and on-site work dwindled, regulatory changes were delayed, and manufacturing needs for PPE expanded. Now that many countries and governments are reducing safety measures like mask requirements, it’s time to examine what changes are here to stay and how our predictions for the “post-pandemic” world hold up.
Especially in Europe, the past several years were supposed to be full of major regulatory changes related to medical devices and clinical trials. Many original implementation and required compliance dates were after March 2020 (when the WHO officially declared a pandemic). Regulatory delays due to the pandemic were inevitable as the industry adjusted to a more remote world.
Personal protective equipment was in sudden high demand for essential workers (not to mention the general public) as cases rose and medical facilities faced both increased demand from patients and decreased provider ability when staff fell ill themselves. Popular online retail platforms were inundated with items advertised as meeting regulatory requirements (like NIOSH) that in fact provided only a false sense of security.
When preliminary and then formal vaccine approvals rolled in across the globe, manufacturers and distributors scrambled to meet demand. The global nature of the supply chain meant more regulations to consider as materials crossed borders. The EU briefly reduced some language requirements to lessen these burdens.
As spikes of COVID positivity have seemed to decrease in severity and length and pharmaceutical companies develop more treatments and vaccines, a slight easing of pressure offers the opportunity for everyone in the supply chain to consider their abilities to quickly shift production. (And the meme-worthy Suez Canal blockage gave the entire world a vivid picture of the downstream effects of an interruption.)
Pivoting from on-site, in-person visits was a formidable challenge for anyone in the clinical trial space. But now participants and administrators alike know that it’s possible to run many trials remotely, and there’s no turning back from that knowledge. While some demographics may still prefer the face-to-face aspect, plenty of new potential patients and researchers/evaluators can access trials from greater distances with the right technology and an internet connection.
The concept of a post-pandemic world is to some degree a fiction—experts now anticipate annual surges of COVID-19 variants through 2025.
And so the ability to pivot—from in-person to remote, from one regulatory region to another—is paramount.
You and your technology partners need to be reliably scalable and agile enough to respond around the globe to changing needs. Lean on our decades of niche subject matter expertise to make this possible whenever disruption occurs. We can help you localize everything for smooth operations no matter what the next surprise may be.