Parexel's COVID-19 expert content
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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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Learn MoreBiosimilars in the time of COVID-19 and beyond
Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...
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Learn MoreCritical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic
The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...
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Learn MoreManaging Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility
Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...
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Learn MoreDesk-based Health Authority inspections: A risk-based approach to compliance
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Learn MoreVendor Audits and cGMPs
Industries are taking ongoing actions in their response efforts to COVID-19 and this includes being prepared for Regulatory Authority CGMP requirements which include Vendor Audits. FDA through...
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Learn MorePerspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19
The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...
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Learn MoreThe Parexel Podcast | Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective
Now more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19...
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Learn MoreCOVID-19 Impact on Rare Disease Patients and Manufacturers
About the Authors Yi Liu, PhD is a Senior Analyst in the Health...
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Learn MoreProtective Antibody Therapy: Preventing Future COVID-19 Outbreaks
About the Authors Dean Giovanniello, RPh., Vice President, co-leads the Health Advances Biopharma...
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COVID-19: Gastrointestinal and hepatic manifestations and implications for clinical trials
Parexel expert Michelle Pietzak, MD reviews current findings and offers practical recommendations for gastrointestinal symptoms of COVID-19 and considerations for clinical trials.
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