The COVID-19 pandemic is unprecedented and unpredictable. Nevertheless, we are remaining flexible as we continue to support pharmaceutical manufacturers and their life-changing work. Regardless of which stage you’re at in the drug development journey — from clinical trials to loss of exclusivity — we’re trusted pharma consultants who have the insight, expertise, and solutions needed to keep you moving.

Since March, our team of experts have tracked the pandemic’s impact on a variety of sectors within the pharmaceutical industry and shared their insights in a special COVID-19 series. Curious how the pandemic might affect your organization? See our round up of articles below:

Impact on DSCSA

COVID-19 has caused a lot of delays in the pharmaceutical industry, but the DSCSA deadlines still loom ahead. Find out how the pandemic may lessen the chances of another DSCSA deadline extension from the FDA and how you should prepare.

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Impact on Marketing & Promotions

Small and emerging manufacturers aren’t likely to be established among HCPs just yet, and with the added barrier of COVID-19, it’s harder than ever for them to reach providers. Find out how manufacturers should adjust their marketing efforts based on size and launch timeline to counteract these new challenges.

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Impact on small companies

From pre-launch to post-launch, COVID-19 is impacting small companies every step of the way. Learn what phases will be affected the most, how funding plays a role, and how small companies should adapt to remain successful.

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Impact on State Licensing

Whether you’re still selecting your 3PLs or are fully operational with your partners, COVID-19 is requiring manufacturers make quick adjustments and decisions. Learn who’s most at risk for seeing an impact on the 3PL process and our advice for completing 3PL inspections.

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Impact on 3PL inspections

Small and emerging manufacturers aren’t likely to be established among HCPs just yet, and with the added barrier of COVID-19, it’s harder than ever for them to reach providers. Find out how manufacturers should adjust their marketing efforts based on size and launch timeline to counteract these new challenges.

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Impact on Clinical Trials

There’s no avoiding it – COVID-19 disrupted the clinical trial process for a number of manufacturers. Find out the challenges manufacturers can expect through the key stages of a clinical trial and how they should react.

This article was written in April 2020, shortly after the initial COVID-19 shutdowns began. Since then, clinical trials have continued to evolve and adapt as manufacturers react to new challenges, procedures, and expectations. We spoke briefly with our experts for an update on how clinical trials continue to be impacted:

  • Trials are continuing and re-starting on a site-by-site basis. Some have special committees to approve new protocols, while some are simply staying closed. No site is operating the same or with the same protocols.
  • Manufacturers are working to prioritize trials, with some moving at a quicker pace, while others are held back until a later date.
  • Enrollment has continued to slow for a variety of reasons. Particularly, patients are not being seen in the office as frequently, causing a decrease in diagnosis numbers and in turn, a decrease in eligible patients.
  • Monitoring patients within the trial is continuing to prove a challenge, however we’re seeing manufacturers adapt to new monitoring protocols on a site-by-site basis.
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Do you need help determining the impact of COVID-19 on your launch and guidance on how to navigate forward?

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