The Business of Contracting With Clinical Trial Sites

Sponsors of clinical trials generally devote substantial resources to regulatory compliance, while often glossing over the business relationships embodied in the clinical trial agreement. The agreement is signed by the sponsor, the institution, and the PI, and enshrines these parties' rights and obligations. Although clinical trials are conducted under regulatory frameworks, they have become big business, and the sponsor should approach negotiation of the clinical trial agreement as a business necessity.

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