At Signant , we understand that successful eCOA implementation requires four pillars: solution, science, scale, and service. Our SmartSignals eCOA is much more than innovative technology; it’s also access to our team of in-house clinical and digital health sciences experts who help study teams navigate common trial complexities. In this video series, our Digital Health Sciences Team answers frequently asked questions and offers best practices to ensure eCOA study success.    

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How do we use PROs to monitor disease incidence alongside reactogenicity in vaccine trials?

When should a patient or an observer complete COA instrument in pediatric trials?

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participant follow up periods, multiphase designs, and critical data management needs. Our SmartSignals solution navigates these challenges via flexible implementation options, built-in alerts that keep PROs on track, and data management services. Greta Marie De Waal, science and medicine clinical scientist, provides insights from her experience on using PROs to monitor disease incidence alongside reactogenicity in vaccine trials.   

Pediatric clinical trials come with unique challenges. Regarding COA selection, our scientists advise on when to use self-completion, proxy, and observer versions. Branden Kusanto, a clinical scientist focused on implementing eCOA best practices on clinical trials in multiple therapeutic areas, shares insights from his experience on completing COAs in pediatric trials.

How can we apply PROM subscales discretely to meet FDA draft guidance for PROs in Oncology trials? 

Considering the recent FDA draft guidance on PROs in oncology clinical trials, oncology PROM strategy may be well suited to a modular approach. The draft guidance recommends PROMs are selected to allow focused, independent measurement of five specific core domains: disease-related symptoms, symptomatic adverse events, the overall impact of side effects, physical function, and role function. Moreover, the frequency of administration of each core domain should vary – with physical function and adverse events identified as requiring more frequent assessment, especially during the early stages of treatment. Both the specificity and measurement frequency of these core domains lead us to consider the independent application of sub-scales within existing validated measures. Senior clinical specialist Viani Figueroa Vazquez provides insights on applying PROM subscales to meet FDA draft guidance for PROs in oncology trials.   

What are best practices in pain and pain management data capture? 

Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often used as experimental treatments in these studies bring stricter drug accountability requirements. Pain patients also face debilitating symptoms that can make participation in studies difficult. Lauren Crooks, science and medicine clinical scientist, provides insights from her experience on the best practices in pain and pain management data capture.