July 2020

Impact of the COVID-19 Pandemic on the Collection and Analysis of Exposure/Drug Accountability in Ongoing Clinical Trials

This paper considers the impacts of COVID-19 on the collection and analysis of exposure/drug accountability data, offering guidance from industry experts on what clinical data scientists can expect in the short term, as well as consideration of future implications.

Impact of the COVID-19 Pandemic on the Collection and Analysis of Missing Data in Ongoing Clinical Trials

The following blog discusses risks, mitigations, monitoring, and reporting of missing data for clinical trials conducted during the COVID-19 pandemic. These considerations are intended for clinical data scientists and are based on current practice, regulatory guidance and literature review. It is our intent to share these points to help inform our industry colleagues and suggest some best practices during this unprecedented time. We caution, however, that efforts are quickly evolving, and we are learning more each day. We look forward to your feedback as we travel this journey together.

NEW to the PHUSE/FDA CSS 2020 – Hackathon and Panel Discussions

Whether you are a long-standing attendee of the Symposium, or new to this event, the innovative and engaging agenda is sure to excite you. It will feature many of the sessions that have been enjoyed in previous years, as well as some new elements. Take a look to see what’s in store…

Impact of the COVID-19 Pandemic on the Collection and Analysis of Protocol Deviations in Ongoing Clinical Trials

The COVID-19 pandemic is an unprecedented event in the context of our clinical trials. It is, therefore, very important to understand the impact of the pandemic on our trials. Protocol Deviations are a key source of insight regarding the conduct of our trials related to ensuring patient safety and the integrity of our trial data.

From PHUSE’s EMEA Director – EMEA Bitesize Single Day Events

Did you attend PHUSE’s virtual EMEA Bitesize SDEs? Take a look below at how the EMEA SDE team converted their presentations that were due to run at face-to-face meetings into two new complementary bitesize days.

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