What’s your observations on non-big pharma - ie small late stage clinical trials startup with a single drug. Would they not vastly benefit from joining a standard protocol?
I can't speak in that space too deeply as we only worked with the largest pharmas.
But in general, the smaller the entity, the harder it is to operate competitively because of the burden of documentation and quality (in this case regarding all of the processes, controls, and SOPs) required for submission for regulatory approval.
Where a lot of smaller biotechs would benefit is more open tools and more standards based interfaces/interchanges. But like health insurance and income taxes, this is a space with a lot of entrenched interests that are extracting rent. A turnkey quality management system (QMS) could run in the 6 figures a year.
It feels like it should be easier and I'd be interested in building an open platform, but it's really difficult to sell into this space because of how conservative it is (in this case, meaning convincing the quality folks on the sponsor side). Even if I were to build a free and open source solution for QMS or regulatory document management or clinical document management (a lot of the burden is document management and records keeping), the chances of it being widely adopted is low without the right influencers and decisionmakers bought in -- but who would do that if they can extract rent?
I tried with two startups and learned the hard way that even with my connections, it was impossible to get biotechs -- even small, single compound biotechs -- to give the product a chance.
Veeva was able to "convert" the industry to cloud because they first started on the marketing side with the Veeva CRM product. It was really the product that broke the barrier for cloud SaaS in the industry. Then off of that, they were able to sell Veeva eTMF. Prior to that, our customers would actually want to walk to our data centers and see the serial numbers on our hardware matched our documented records....
But in general, the smaller the entity, the harder it is to operate competitively because of the burden of documentation and quality (in this case regarding all of the processes, controls, and SOPs) required for submission for regulatory approval.
Where a lot of smaller biotechs would benefit is more open tools and more standards based interfaces/interchanges. But like health insurance and income taxes, this is a space with a lot of entrenched interests that are extracting rent. A turnkey quality management system (QMS) could run in the 6 figures a year.
It feels like it should be easier and I'd be interested in building an open platform, but it's really difficult to sell into this space because of how conservative it is (in this case, meaning convincing the quality folks on the sponsor side). Even if I were to build a free and open source solution for QMS or regulatory document management or clinical document management (a lot of the burden is document management and records keeping), the chances of it being widely adopted is low without the right influencers and decisionmakers bought in -- but who would do that if they can extract rent?
I tried with two startups and learned the hard way that even with my connections, it was impossible to get biotechs -- even small, single compound biotechs -- to give the product a chance.
Veeva was able to "convert" the industry to cloud because they first started on the marketing side with the Veeva CRM product. It was really the product that broke the barrier for cloud SaaS in the industry. Then off of that, they were able to sell Veeva eTMF. Prior to that, our customers would actually want to walk to our data centers and see the serial numbers on our hardware matched our documented records....