Good discussion topic. I found this interesting link that provides a helpful visual to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical trials would be done after the validation tests and reports are completed. Also, the DDP, DID, DSD and design output (including the verification and review) must all be completed before sending the product into the validation stage.

http://www.raps.org/WorkArea/DownloadAsset.aspx?id=3566