Bioanalysis monitoring by sponsor [Bioanalytics]

posted by dshah – India, 2021-03-02 16:19 (152 d 13:57 ago) – Posting: # 22238
Views: 982

Greetings All!
Generally sponsors does monitoring for clinical phase, but up to how much extent sponsor can monitor ongoing bioanalysis? As per WHO- QA of CRO can decide up to which extent the data can be shared during ongoing analysis, but can sponsor completely monitor the bioanalysis?
In my opinion, sponsor shall not monitor the BA phase as they can influence the analysis and ultimately the study outcome. They may assign thir party for monitoring of BA phase.

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