Navigating COVID-19 to Support Next-Gen Patient-Focused Treatments
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COVID-19
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Whitepaper: COVID-19 Vaccination in Cancer Patients
In this whitepaper, we address the unique variables, optimal timing, and immunogenic considerations for vaccinating individuals with cancer.
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COVID19 The Great Decentralized Clinical Trials Accelerator
Learn more from Roz Round, Parexel’s Vice President, Patient Innovation Center about how Decentralized Clinical Trials can help ensure patient safety and enable ongoing trial participation.
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The Special Approval Pathway (SAP) for COVID-19 related products in China
Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate...
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NMPA 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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GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation.
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The future is now: Decentralized clinical trials during the pandemic and beyond
Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.
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FSP and COVID-19: Impact on Clinical Trial Development
The functional service provider (FSP) outsourcing model enables sponsors to efficiently and cost-effectively manage workforce needs across clinical portfolios. FSP models proved to be a strategic...
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Critical Global Pandemic Safety Considerations: FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with C
On June 19, 2020, FDA released a Guidance for Industry (GFI) entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products...
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Using 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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Putting 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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COVID-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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Biosimilars 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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Managing 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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Perspectives 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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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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COVID-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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Source Data Verification expectations during COVID-19
It is hard to grasp the full extent of disruption brought on by COVID-19 across everything it touches, and clinical trials are no exception. Regulatory authorities have been issuing guidance over...
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BCP considerations during COVID-19
Business Continuity Plans (BCP) is not a novel concept, but COVID-19, with its global impact, unceremoniously put many companies’ BCPs to the test, steadily pushing the limits of BCP adaptability...
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COVID-19 and the effect on Cellular Therapy Trials
The World Health Organization states that COVID-19 has infected over 750,000 people in 203 countries as of March 31, 2020. China and the United States, two of the countries hardest hit by...
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