Traditional trial start-up workflows often follow a sequential path, from feasibility to contracting, then regulatory ...

Successful clinical trial conduct balances participant safety, treatment efficacy and operational feasibility. But slow patient identification and enrollment, cost overruns and missed deadlines pose a ...

There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials to take a biosimilar from conception to market. However, there is minimal literature describing ...