Videos

This video series discusses the impact of implementing risk-based quality management (RBQM) and decentralized clinical trials (DCTs) from the clinical operations point of view.

Practically Speaking: Driving Clinical Transformation 

As the initial COVID-19 pandemic begins to resolve in the form of vaccines and treatment pathways, research into the long-term effects of COVID is building. In response, in December, Congress provided $1.15 billion in funding over four years for NIH to support research into the prolonged health consequences of SARS-CoV-2 infection. This roundtable of experts from various stakeholder groups will discuss the current research into long-haul COVID, or PASC; disparate theories of causes; challenges in research and diagnosis, as well as PASC potential in drug development.

Studying Long COVID in Drug Development

Roundtable: Synthetic Control Arms and Regulatory/HTA Requirements

In a recent virtual roundtable discussion, industry experts Jim Streeter, Alison Holland, Hassan Kadhim, Craig Lipset, Josh Rose, and Craig Serra shared their insight on the challenges faced in implementing decentralized trials and how to address them. Along with the roundtable are video discussions covering the cost and feasibility of a toolkit approach to decentralized trials, the significance of minimizing burden to patients and sites, and the reality of regulatory hurdles.

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