Phase II-IV Services Sample Clauses

The 'Phase II-IV Services' clause defines the scope and terms under which services related to clinical trial phases II through IV are provided. It typically outlines the responsibilities of the service provider in conducting, managing, or supporting clinical studies that occur after initial safety testing, such as efficacy trials, expanded safety monitoring, and post-marketing studies. This clause ensures that both parties understand the expectations, deliverables, and regulatory requirements associated with later-stage clinical research, thereby promoting clarity and reducing the risk of misunderstandings during the execution of these services.
Phase II-IV Services. The provisions in this Section 7.2 apply only to the provision of Phase II-IV Services. “Phase II-IV Services” shall be defined as (i) all non-laboratory Clinical Development Activities relating to a phase II, phase III or phase IV clinical trial, including, but not limited to, monitoring, data management, and biostatistics; (ii) medical communications Services and (iii) all non-laboratory consulting Services, including, but not limited to, regulatory consulting and general drug development consulting. Phase II-IV Services shall not include any Non-Phase II-IV Services.
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