I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

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Parexel Insights

An overview of the recent Executive Order on Critical Drugs Made in America

09.11.20 - 5 min - The EO creates several new requirements aimed at building reliable, long-term domestic production of essential drugs and devices, including their components and input materials. These include...

Successful wearable device selection for the evolving clinical trials landscape

09.08.20 - 2 min - There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors consider which devices best meet their requirements when running a clinical trial.

The Move Toward Global Standards: Navigating New EAEU Guidelines

09.02.20 - 5 min - Our regulatory affairs experts outline the new EAEU guidelines, and an effort to create global standards across the board. Read more...

The Special Approval Pathway (SAP) for COVID-19 related products in China

08.21.20 - 3 min - 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 COVID-19 related drug development.

NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

08.20.20 - 4 min - 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 considerations. Read more in our latest blog.

News Highlights

Chitkara University collaborates with Parexel International to offer a 2-Year M.Sc Program in Pharmacovigilance & Clinical research

Chitkara University became the first University in the region to offer a postgraduate program on Pharmacovigilance in alliance with leading clinical research organization (CRO)

 

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Parexel and Pfizer Enter Next Phase of Decade-Long Partnership

Alliance aims to speed delivery of break-through therapies to patients

 

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Parexel’s Deb Tatton Named to 2020 PharmaVOICE 100

 

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