Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements for study sites, end users, training, endpoints and follow up are all variables. This paper examines the key differences and how those impact clinical development with a focus on the US regulatory environment.
IN CASE YOU MISSED IT
- Bayer is making a big digital health play
- B. Braun launches DoseTrac Enterprise infusion management software
- Patient Training is Broken – And Everyone is Paying For It
- Analysts still high on Insulet despite Medtronic’s EOFlow buy, stock market reaction
- Convatec, Beta Bionics partner on iLet bionic pancreas