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- This is the full contract that is prepared by the CRO for the Sponsor to outline the complete cost of running a clinical trial.
- This is prepared after the protocol is final.
- The FSWO is provided to the Sponsor for signature 1-month prior to the FPI date.
- CTAs and vendor contracts cannot be signed until a FSWO is signed with the Sponsor or we are working at risk.
- Vial provides a fixed budget promise so as not to riddle the Sponsor with contract amendments throughout the study lifecycle.
- An MSA should have been signed at this stage.