Parexel's COVID-19 expert content
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Learn MoreHow COVID-19 Testing Demand Threw off Thermo Fisher’s Acquisition of Qiagen
About the Authors Aaron Dy, Ph.D. is a Senior Analyst in the Health Advances...
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Learn MoreI Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19
On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...
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Learn MoreBiopharma R&D in the Post-COVID World
About the Authors Steven Chang, Ph.D. is a Senior Analyst in the Health...
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Learn MoreeBook: Biopharma in the COVID-19 World
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Learn MoreThe Special Approval Pathway (SAP) for COVID-19 related products in China
The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005. SAP is...
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Learn MoreNMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020
Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...
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Learn MoreAgainst All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?
Key Takeaways The COVID-19 pandemic has drawn attention to international efforts to promote...
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Learn MoreThe New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...
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Learn MoreDemystifying SARS-CoV-2 Testing for COVID-19 (Third Edition – Part 1: Updates and Trends)
Click here to download the full presentation. SummaryAs the world continues to battle...
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Learn MoreWhat’s Around the Corner for FDA Inspections?
There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...
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An opportunity in a time of crisis: COVID-19 and the new pragmatism
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Learn MoreFDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices. Numerous...
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Learn MoreeBook: Digital Health and the Global Pandemic
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View NowEMA Guidance: Management of Clinical Trials - What it means for Patients?
A lay summary for patients participating in clinical trials
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Learn MoreUsing risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19
During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...
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Learn MorePutting the Pandemic in Plain Language
The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...
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Learn MoreSARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future
About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...
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Learn MoreKeeping ahead of the regulatory curve – Stay open for business
On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...
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Learn MoreCOVID-19: Digestive symptoms of the novel virus and implications for clinical trials
As the entire healthcare ecosystem grapples with the COVID-19 virus, more evidence surfaces every day of manifestations beyond fever, respiratory symptoms and fatigue. In fact, a recent...
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Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
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