IND/IMPD - For an adaptive Clinical trials design (where single phase 2&3 study planned ):
a) is there opportunity to connect with FDA/EMA post phase 2 results are available or not to discuss and plan further Phase 3 part ?
b) Do we need provide CMC data as per Phase 2 requirements or phase 3 requirements to be fulfilled at the time of protocol submission??
c) any points to consider when we plan for adaptive clinical trials
appreciate your help in providing feedback to above points, thanks in advance.
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Maddigunta Sadasivarao
biocon limited
gugugram, haryana
India
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