Thought Leadership

Blog & Article
Journal Article
Health authorities are turning to digitalization to streamline their processes in response to global crises (such as the COVID-19 pandemic) that have affected the supply chain. The growing complexity of information and data in regulatory submissions has encouraged health authorities to implement structured data submissions and centralized e-submission processes through shared workspaces (1, 2). Some ongoing initiatives seek to simplify review and assessment processes through increased global cooperation and harmonization.
Time is rapidly running out to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR). A key challenge for sponsors is ensuring they are proficient in the Clinical Trial Information System (CTIS) and understand the transition requirements.
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