Decentralized Clinical Trials - a pathway to more subjects and greater diversity?
…all companies should examine whether and how they can decentralize components of their studies. If so, it may help with enrollment, meet diversity requirements, and improve the overall study data, leading to better-informed decisions and regulatory submissions. However, it needs to be accompanied by well-thought-out strategic plans.
Besides good surf and BBQ, what can Australia offer your clinical program ?
It is a long flight, a day ahead of the US, and their slang requires a handbook but their R&D and biotech industry could be a great fit for your early phase clinical trial.
Diversity Action Plans - What do they mean for my clinical program?
A new draft guidance that will impact how we think about study enrollment has been released. In June, the FDA published the draft guidance “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”. How will it impact your clinical program?
Medtech 2025: Prepare for What’s Next
Join me on Oct 30 for a panel discussion on what is going to impact the Biotech industry in 2025.