I worked in the pharma space building document management systems that supported clinical and pre-clinical processes (mostly clinical, some R&D). After a while

I worked in the pharma space building document management systems that supported clinical and pre-clinical processes (mostly clinical, some R&D). After a while, one starts to understand the need for the rigor. If some cluster of patients suffers some injurious adverse effect pre- or post-market, the FDA and a bunch of lawyers wants to trace the history of development to understand how to assign responsibility. Software systems in this space are validated quite rigorously against their functional and technical design specifications to verify that the records produced are traceable. Software validation in this space works kind of like GPL licenses: the sponsor (like a Merck or a Pfizer) is responsible for validating software from vendors when it is supporting a GxP process. Those vendors are then responsible for validating not only their systems, but all dependent systems as well. (A lot of it is risk-based and obviously a lot of the methodology, guidance, and interpretation has evolved since the cloud era. But we used to have to take our customers on tours of our data center and their auditors would match the specifications of the hardware!) I think it's one of the reasons why -- despite this process being extremely high in "schlep" -- there are few startups in this space because the barrier to entry is quite high. Even having 15 years of domain experience and running a team delivering production systems used by pharmas to run their trials, I don't think I'd want to do a startup in this space. There's a really great HN thread on this that resonated with my experience that I bookmarked a while back: https://news.ycombinator.com/item?id=33545209 https://news.ycombinator.com/item?id=33545209