The Software as a Medical Device [SaMD] Regulatory Landscape in the US and Europe
In this article we explain how AI and machine learning will become an integral part of our lives, just as medicines and medical devices already are.
Potential Repurposing of Favipiravir in COVID-19 Outbreak Based on Current Evidence
To assess suitability of Favipravir for repurposing in COVID-19, we conducted a mini-review of clinical trials using Favipiravir as an investigational drug for various indications in all 18 primary clinical trial registries in the WHO Registry Network and identified 19 such trials.
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Mapping of Oncology Specific Domains in SDTM
The most important part of an Oncology trial is the assessment of tumor lesion and disease responses throughout the study.
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The reliability of Mini Nutritional Assessment (MNA) questionnaire in screening malnutrition among elderly aged 60 years and above
Malnutrition in old age is a significant problem. Mini Nutritional Assessment (MNA) questionnaire is a widely used international questionnaire to evaluate the nutritional status of elderly.
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Automating SDTM – Get it prepared with your voice
FDA mandates that data submissions for all studies conducted after 2016 must be in SDTM format. Majority of the sponsors are now looking at ways to generate datasets in a cost-effective manner.