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The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact. This experienced individual’s oversight ensures seamless communication, promotes data accuracy, and drives proactive problem-solving.
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It is common for contract research organizations to assume that, because they have completed numerous regulatory submissions, they know what a “good” one looks like and can start right away. However, three essential elements contribute to a repeatable, adaptable submission process. Find out what they are, here.
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To understand the added value that a Medical Monitor brings to a clinical study and the attributes that enable them to best serve a study team, it is important to understand the Medical Monitor’s responsibilities and the challenges they may encounter throughout a study.
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Often, the catalyst for safety program issues is the use of multiple safety vendors. A combination of strategies and tools can help navigate the challenges that arise from contracting multiple safety vendors within one or more investigational medicinal product (IMP) development programs.
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