In a clinical study with biomarker data managed by an external partner, what should be the data flow? Is there an obligation to store these data into the clinical database? Or can they be transfered directly to statistician team? What about the codin



In a clinical study with biomarker data managed by an external partner, what should be the data flow? Is there an obligation to store these data into the clinical database? Or can they be transfered directly to statistician team? What about the coding or anonymization of these type of data at CRO and at Sponsor?