January 2021 - Clinical Research Info

Summary of Product Characteristics (SPC/SmPC): Introduction, Overview, and relevance in aggregate reports

Summary of Product Characteristics (SPC/SmPC): Introduction, Overview, and Relevance in aggregate reports

Post last modified:January 25, 2021
Reading time:26 mins read
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In this article, I mean to introduce a summary of product characteristics (SmPC or SPC), what it is, contents (the sections it has), a high-level overview of various key SPC sections (with focus on sections 4.4 and 4.8), and its contents, what makes SmPC so special,

Clinical trial site visit

Types of Clinical Trial Site Visits – CRA

Post last modified:January 13, 2021
Reading time:14 mins read
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A CRA could be employed directly by the sponsor companies (Pharmaceutical, Biotechnology or any research company) of clinical trials or by Contract Research Organizations (CROs) also referred to as Clinical Research Organizations (As per ICH GCP) that conduct clinical trials on behalf of the sponsor companies. Let's learn about the…