We've heard a lot about the 'new normal' lately.  The world we knew at the beginning of 2020 is very different from the world that we are now cautiously reopening. Here in Massachusetts, the final phase of reopening is even called "The New Normal".

Everyone I speak to has an opinion on how we should deal with this new normal.

I have trouble just dealing with it: 

  • Dealing with it is reactionary.
  • Dealing with it is trying to stay afloat.
  • Dealing with it is just SURVIVAL.

And just surviving isn't a strategy. We need to do more than just deal with the new normal. 

We need to CREATE our new normal.

We need to seize this time as an opportunity to come out of the crisis stronger and better positioned to succeed.  This is true both personally and professionally; it applies equally to individuals and to organizations. 

That said, a strategy is only as good as the information that goes into it.  This is why Advera has pulled together pharmacovigilance thought leaders in a series of live roundtable discussions during the pandemic. 

Our last discussion took place on May 19th with a fantastic panel that was full of tactical advice on how to not just deal with the new normal, but how to succeed in the new normal.

You can access the full recording here, but we also wanted to share some of the key takeaways. 

1. Providers are starting to see patients, there is a big backlog, and they are very busy.  Most tier 1 and tier 2 clinical trials have resumed. With the remote nature of past visits, our experts have seen a shift to patient-centric reporting where the patient has to do more work to report adverse events. As this will likely continue for some time, better remote monitoring solutions and technology will be needed. 

2. Operationally, our experts see two types of pharmacovigilance organizations: Those that already had well established business continuity and disaster recovery plans, and those that didn’t. If you fall into the latter category, don’t just put together a pandemic response… put together a long term solution. that covers all sorts of potential disaster risks.

3. While it is certainly not business as usual, regulators including FDA have not materially changed requirements. Some reporting may be delayed. But FDA in particular is concerned with how reporting volume and rates in general will effect their signal detection activities. 

4. Q1 2020 FDA Adverse Event Reporting System (FAERS) data have been released, and Advera has cleansed and normalized those data. There really was not a lot to report yet in terms of changes to reporting. We’ll have to wait until Q2 to really see if there was a material impact.

5. Companies that may have resisted technology change previously are being forced into the digital world, both in terms of processes and data analytics. Traditional signal detection needs to be complimented with other, real-world data such as registries and EHR.  Having a next generation platform for signal detection and management that is equipped to embed these changes into PV workflow is critical

6. Finally, Pharma IT budgets are not being materially affected, however the types of projects that are being moved ahead have changed. Earlier in the year there was more talk about AI, NLP, etc… but now that weaknesses have been uncovered in infrastructure, the focus is more on what technology can be put in place to ensure the next 18 months run smoothly. 
These were only a few of the tactical insights that our panelists discussed. Click the button below to watch the full recording of the roundtable. 
Watch Recording Now
On behalf of everyone at Advera Health, I hope that these insights can help you CREATE the new normal for your organization. 
If you have any questions or would like to discuss how Advera can help, please do not hesitate to get in touch. 

Topics: FAERS, Signal Management, Pharmacovigilance Software, COVID-19

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.