Deepa Subramaniyan
Deepa Subramaniyan is Senior Clinical Trial Regulatory Lead at F Hoffmann-La Roche Ltd
JournalCOMBINE EU pilots: Roche’s experience as first pilot participants
Drawing on two successfully approved COMBINE pilot combined studies, this article shares practical experience of coordinated submissions and assessments, highlighting the benefits, operational challenges and potential solutions for making cross-regulation studies more efficient.