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Parexel Insights

Critical Global Pandemic Safety Considerations: FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

06.29.20 - 3 min - 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 Manufacturing.

Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

06.18.20 - 4 min - 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 trial subjects become infected with SARS-CoV-2.

Risk-Based Monitoring: The Right Solution for a Turbulent Present and an Uncertain Future

06.18.20 - 5 min - While the impact of the pandemic on clinical trials has been massive, the requirements for safeguarding patient safety, data quality and study integrity remain as critical as ever. What has changed, however, is the ability to monitor trials in normal ways. How can the industry adapt? And what are the implications for the conduct of future studies?

Putting the Pandemic in Plain Language

06.17.20 - 3 min - 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 that have been forged between the public and medical science?

The Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

06.05.20 - 1 min - In this podcast, clinical industry experts discuss the progress made in cell and gene therapy as presented at ASCO and how the industry can continue to move these developments forward today and in the future.

News Highlights

Parexel and TriNetX Partner to Advance Real-world Data Use in Clinical Development

 

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Parexel Adds APANDEMIC and Datavant to Lead Ongoing Advancement of #KeepingPatientsFirst Platform

 

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Parexel and Society for Clinical Research Sites Host Joint Summit of Site and Patient Advisory Councils Focused on Optimizing Site and Patient Relationships in Clinical Trials

Launch of company’s Site Advisory Council and meeting with Patient Advisory Council held on International Clinical Trials Day 2020; address clinical trial challenges during pandemic

 

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