This is so, so interesting. Thanks so much for posting this!
The author already touched upon a few hypotheses why the industry has arrived at this state. There's one I'd like to highlight: The author, now having gone through this experience, would actually be in a perfect position to found their own CRO and implement all their efficiency learnings there. However, they probably look back upon this experience and think it was super painful and would prefer to do fun stuff like developing software instead.
That, for me, is the main reason. There are smart, structured, pragmatic people who got acquainted with this industry, but they choose to leave it.
And that's sad!
So the solution would be to find a group of smart, structured, pragmatic people with a high tolerance for bureaucratic pain and give them the resources to make this industry more efficient.
And here's my plug: That's exactly what we're doing at OpenRegulatory [1], albeit for medical device software and not for clinical trials. Among other things, we've published all our document templates for free (also on GitHub), host a free Slack community for companies to help each other out, and offer a compliance SaaS with transparent and fair pricing. It's still a long way, but it's a start :)
Your company is very interesting. I briefly looked over the website, but couldn't tell what country(ies?) you operate in? My assumption is the regulatory requirements of each country are dramatically different, so seeing the pricing in not $ makes me think it's unlikely you offer services in the US, for instance.
As jtwaleson already correctly replied (thanks!), we're based in Germany and are mostly focused on EU regulations. The "good" news is that if you gain regulatory approval within the EU you can bring your device to market in any EU country.
There's quite an overlap with US (FDA) regulations but we're less experienced there.
Most startups (at least in my bubble?) focus on one of those two areas.
The author already touched upon a few hypotheses why the industry has arrived at this state. There's one I'd like to highlight: The author, now having gone through this experience, would actually be in a perfect position to found their own CRO and implement all their efficiency learnings there. However, they probably look back upon this experience and think it was super painful and would prefer to do fun stuff like developing software instead.
That, for me, is the main reason. There are smart, structured, pragmatic people who got acquainted with this industry, but they choose to leave it.
And that's sad!
So the solution would be to find a group of smart, structured, pragmatic people with a high tolerance for bureaucratic pain and give them the resources to make this industry more efficient.
And here's my plug: That's exactly what we're doing at OpenRegulatory [1], albeit for medical device software and not for clinical trials. Among other things, we've published all our document templates for free (also on GitHub), host a free Slack community for companies to help each other out, and offer a compliance SaaS with transparent and fair pricing. It's still a long way, but it's a start :)
[1] https://openregulatory.com