Join Dr. Erica Troksa, Associate Director, Translational Biomarker Solutions and Global Immunology, and Immunology Manager Katie LaVelle, as they discuss COVID-19 assay development focusing on the area of Immunology, including antibody detection, FDA guidance and cytokine and flow assays.
As clinical trials are incorporating an increasing number of sources of non-case-report-form (CRF) data from wearable devices and various laboratories, management of clinical data must address larger, disparate volumes of external data sources.
Many drug development sponsors are interested in understanding how a digital biomarker strategy can improve patient-centricity their trial. However, may feel uncertain about where - and sometimes even why - to start.
The integrated summary of safety (ISS), integrated summary of efficacy (ISE), and Study eSubmission deliverables are considered key components of a New Drug Application (NDA) for the U.S. FDA as well as other regulatory agencies around the world.
When the global clinical trial industry was suddenly forced to adapt to unprecedented challenges, traditional trial conduct models were upended. Some trials were delayed or even cancelled. Yet other trials thrived and still more were able to restart after adopting decentralized clinical trial (DCT) methodologies.
You want to eliminate the burden of managing external data sources, so do we. Join our session to learn about the latest technologies and methodologies used to manage external data sources.
At Covance, they know that time is of the essence across their diabetes trials. Developing these trials in the most cost-efficient manner makes upfront planning crucial, but interrogating the best data resources to augment team expertise is a difficult task.
Preserving Data Quality in Phase I Studies During COVID-19: A CRO's Perspective from the ExL Clinical Quality Oversight Forum recorded on October 21, 2020.
