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PDF preview of the Streamlining the Clinical Trial Workflow from Protocol Design to Regulatory Submission use case, available for download.

Protocol amendments and clinical trial regulatory submission are two areas at either end of the clinical trial life cycle that threaten to disrupt a study’s timeline. See how Citeline addresses these issues head-on.


The situation

A sponsor in the early stages of planning a breast cancer clinical trial wanted to address potential stumbling blocks from the start. Its main concerns were costly protocol amendments and clinical trial regulatory submission, two areas at either end of the clinical trial life cycle that could threaten to disrupt the study’s aggressive timeline.


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