Parexel Blog
Parexel Blog
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Learn MoreBecoming Proud
I don’t have a great answer to the question, “when did you first know you were gay?” I simply cannot remember a time when I didn’t know. I do know, however, that it occupied a very negative part...
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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 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 MoreRisk-Based Monitoring: The Right Solution for a Turbulent Present and an Uncertain Future
Amidst the human tragedy of the current pandemic, clinical trials must go on as sponsors strive to develop and deliver life-saving treatments. While the impact of the pandemic on clinical trials...
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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 MoreThe Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy
In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster,...
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Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
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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 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 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 More
The 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 MoreThe Parexel Podcast | Episode 10: The emerging role of wearables in clinical trials
The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs)....
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Learn More
The Parexel Podcast | Episode 10: The emerging role of wearables in clinical trials
The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs)....
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Learn MoreCOVID-19 and the impact on pediatric clinical trials
The COVID-19 global pandemic has had a significant impact on the conduct of pediatric and adult clinical drug trials. Many trials have halted enrollment, and there are multiple challenges with...
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Learn MoreConsiderations for protecting your business and employees from COVID-19
This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.
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