Bioprocessing and Biologics Risk Attendant to COVID-19

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Parexel Insights

Tech Solutions for Tomorrow's Life Sciences Industry

Learn how Parexel's partnership with Microsoft is working to accelerate R&D.

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Imagining & Realizing Tomorrow's Life Sciences Industry

Chief Commercial & Strategy Officer, Peyton Howell, on how keeping patients at the heart of our efforts will improve outlooks for the industry.

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RIM Blog Series - Part 2: Mind the gap

Now that you know what RIM is, learn why it must have a robust structure for defining & managing data in part 2 of this series.

 

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Supporting the Journey from Clinic to Bedside

Learn how strategies that extend the bench to bedside philosophy can optimize outcomes for precision medicine trials.

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Patient Story: Tina

Tina Aswani Omprakash shares her experience of living Crohn’s disease and participating in a clinical trial.

 

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Back To The Future – Are You Prepared To Meet Unprecedented Demand to Use Old Drugs for New Purposes?

03.27.20 - 2 min - There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on pharmaceutical supply chains when additional capacity needs to come on-line with existing facilities, restarting manufacture, technology transfer to new or alternate facilities and using new or alternate suppliers for components.

COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions

03.27.20 - 6 min - Addressing similarities and differences in clinical trial conduct guidances across European Union, FDA, PMDA, NMPA and MHRA

FDA creates new temporary policy on the preparation of hand sanitizer products

03.26.20 - 3 min - The FDA is moving quickly to implement temporary Guidance to provide flexibility to those pharmacies and compounding centers to produce sanitizing solutions required to meet institutional and consumer demands. However, the current enforcement environment and regulatory actions against compounders may impact their ability to meet this demand, as they are focused on manufacturing critically needed drug products and/or are remediating current Regulatory enforcement activities (DOJ Consent Decree, etc.) that have impacted production and future viability of these firms.

COVID-19: Regulatory Impact

03.25.20 - 6 min - Regulatory strategies, applications, timelines, meetings, inspections and how regulators are working now.

FDA Takes Action to Accelerate Availability of COVID-19 Diagnostic Tests

03.24.20 - 5 min - In a direct and timely action to address the acute shortage of diagnostic tests currently available to test for COVID-19 disease, the FDA has issued a new policy that enables both commercial manufacturers and CLIA-certified laboratories to manufacture and distribute validated tests.