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International Clinical Trials

Accelerating COVID-19 and Other Vaccine Trials Without Sacrificing Data Quality

Researchers conducting vaccine clinical studies face unique challenges compared to those conducting trials in other disease states. These stem primarily from the significant time pressures that are created by varying seasonal heath concerns and the need to fast-track studies during outbreaks such as the coronavirus (COVID-19) (1).

Clinical trial sponsors need reliable methods to capture critical data directly from trial participants as they evaluate the safety and effectiveness of vaccines during development. Sponsors need to be able to implement these methods quickly to prevent trial delays.

Digital solutions are overcoming the data capture challenges that face vaccine developers and delivering the important data they need to bring new vaccines to market sooner.

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About the authors

Matt McCarty, Vice President, Digital Patient at ERT, is responsible for defining and leading the product strategy for ERTís digital patient product line, with a focus on direct-to-patient enablement in both post-approval research and patient support. Matt has spent the last 12 years leading teams and innovating products in both the clinical research and commercial healthcare settings to reduce patient burden of participation and to support patients in their healthcare journey.

Nadeeka Dias, PhD, Senior Clinical Science Advisor at ERT, is a clinical neuroscientist with over eight years of in-depth experience in the design and management of human clinical research. She has extensive expertise in psychiatry and neuropharmacology, as well as proficiency in the administration and scoring of psychological/CNS assessments. She is skilled in scientific consulting to support early to late phase clinical trials, including knowledge of relevant regulatory guidance, instrument development and validation, as well as the use of eCOAs and rater training
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