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Doesn't seem to be an organizational shit show per glassdoor and the limited chatter that got back to me personally. 

Also agree with Brad here, smart people with experience and a financial head start - and it's becoming a trope - so what gives? Here's a shot that probably has not enough detail to be accurate but also won't be completely wrong:

1) Countervailing forces from investors/operators - Taking on money comes with strings. Grow at all costs. This often means a little white lie here and there about capabilities in order to win business. Staffing up with marketing and sales instead of operational expertise or engineering capacity. Eventually the white lies grow into legitimate misleading statements and won business, but then the deliverables aren't there. Much of the revenue in this industry is tied to execution/delivery - and even to the degree that it isn't: word gets around. 

2) Expectations and reality gap led to overvaluation - 2021: "#nevergoingback trials have changed forever, every study needs remote optionality, new tech/approaches will transform delivery timelines and study access which are both billion-dollar problems. 2022 "Hey the second we get a chance to go back, let's go back! We want to operate within well-trodden regulatory pathways, not branch off and risk some freak outlier costing us an FDA approval" 

The companies with an appetite for fully remote/virtual studies does not extend to those investigating drugs for the most part. DTx, consumer health - sure. But the sky-high valuations were based on pitch decks that included partnerships and budgets from top pharma, which may have one or two projects in the works but looks nothing like wholesale adoption.

3) Cost of Revenue - SaaS is easy: build the thing, get adoption, charge monthly forever. The problem is that no one really wants or needs additional software to run studies. Sure, some stuff is attractive and/or makes it incrementally easier - but most of that tech was in play pre-pandemic. So there was a pivot to activating untapped patient populations, trying to ride the coattails of diversity and inclusion as it takes a turn in the buzzword center ring. The problem is, having mobile nurses in Dallas really just activates Dallas - which you can already do with a site. Sure, some people are far enough away they wouldn't want to drive to a site but honestly, how many more people is that? For those who have mobility issues there is emergent data that those populations are exactly the ones who do not WANT healthcare professionals coming into their homes. 

Now we get a little sprinkle of #1 (overpromising) to cover up number 2 and the pivot: We can add the equivalent of 20 sites to your study with one virtual site! How? Mobile nurses... instead of having them concentrated in Dallas, we'll either have a huge network (expensive) or we'll just fly them somewhere whenever we get a patient! If you own a site, imagine the types of studies where your patient visit would pay enough to cover round trip airfare and a hotel, in addition to all the other line items. Now imagine a regular study visit, keep the cost, but add the expense of airfare and hotels.... it becomes an accounting problem in short order.

There are probably a million nuances I'm missing - and maybe even some big rocks too - but this stuff is for sure contributing. 

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Quote from Guest on September 8, 2023, 11:52 am

Doesn't seem to be an organizational shit show per glassdoor and the limited chatter that got back to me personally. 

Also agree with Brad here, smart people with experience and a financial head start - and it's becoming a trope - so what gives? Here's a shot that probably has not enough detail to be accurate but also won't be completely wrong:

1) Countervailing forces from investors/operators - Taking on money comes with strings. Grow at all costs. This often means a little white lie here and there about capabilities in order to win business. Staffing up with marketing and sales instead of operational expertise or engineering capacity. Eventually the white lies grow into legitimate misleading statements and won business, but then the deliverables aren't there. Much of the revenue in this industry is tied to execution/delivery - and even to the degree that it isn't: word gets around. 

2) Expectations and reality gap led to overvaluation - 2021: "#nevergoingback trials have changed forever, every study needs remote optionality, new tech/approaches will transform delivery timelines and study access which are both billion-dollar problems. 2022 "Hey the second we get a chance to go back, let's go back! We want to operate within well-trodden regulatory pathways, not branch off and risk some freak outlier costing us an FDA approval" 

The companies with an appetite for fully remote/virtual studies does not extend to those investigating drugs for the most part. DTx, consumer health - sure. But the sky-high valuations were based on pitch decks that included partnerships and budgets from top pharma, which may have one or two projects in the works but looks nothing like wholesale adoption.

3) Cost of Revenue - SaaS is easy: build the thing, get adoption, charge monthly forever. The problem is that no one really wants or needs additional software to run studies. Sure, some stuff is attractive and/or makes it incrementally easier - but most of that tech was in play pre-pandemic. So there was a pivot to activating untapped patient populations, trying to ride the coattails of diversity and inclusion as it takes a turn in the buzzword center ring. The problem is, having mobile nurses in Dallas really just activates Dallas - which you can already do with a site. Sure, some people are far enough away they wouldn't want to drive to a site but honestly, how many more people is that? For those who have mobility issues there is emergent data that those populations are exactly the ones who do not WANT healthcare professionals coming into their homes. 

Now we get a little sprinkle of #1 (overpromising) to cover up number 2 and the pivot: We can add the equivalent of 20 sites to your study with one virtual site! How? Mobile nurses... instead of having them concentrated in Dallas, we'll either have a huge network (expensive) or we'll just fly them somewhere whenever we get a patient! If you own a site, imagine the types of studies where your patient visit would pay enough to cover round trip airfare and a hotel, in addition to all the other line items. Now imagine a regular study visit, keep the cost, but add the expense of airfare and hotels.... it becomes an accounting problem in short order.

There are probably a million nuances I'm missing - and maybe even some big rocks too - but this stuff is for sure contributing. 

This is a great post and I sincerely believe you're probably pretty close to the truth.

From what I've gathered about some of these companies, they sure seem a lot more focused on having huge c-suites and doing pointless webinars with planted questions. But at the end of the day, they really aren't doing that much revenue generating stuff.

I do laugh when I recall #nevergoingback because you aren't lying - everyone immediately went back as fast as humanly possible.

I've always found the speed of saturation in this space so crazy because, like you mention, I've always felt it will be a very small number of studies that are truly appropriate for all these bells and whistles. 

Definitely a whole lot more to unpack in your post (and hope others will) but I think that's a great analysis.

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
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Quote from brad on September 7, 2023, 7:37 pm

I'm not really that smart but I have to start wondering if there is some common thread with these companies who raise a shitload of money only to flounder. These are smart people (presumably). They have experience. They have connections. But they still can't execute. I have a hard time understanding how. I feel like if a dummy like me can bootstrap a small site network that can gross a few million every year they could do much better with tens (sometimes hundreds) of millions to work with.

What gives?

DCT's will struggle because they are a pain for sites, and CRO leadership routine is out of touch with site challenges, so that another "industry" side DCT fails doesn't shock me. I don't see the DCT model truly working unless if comes from the site perspective. Sites build from the bottom up and plug the holes along the way because that's how they earn their money. I struggle to see the get paid, then do the work model working in DCT.

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There is another underlying connectivity problem in trials that limits use of “DCT” or really anything other than traditional site. All of these companies created yet another point solution, with very little underlying tech to connect the ecosystem. They all call themselves “connected” or full DCT platforms…untrue. It’s just a small piece of the overall study data collected going into each system and then a lot of manual coordination efforts to “make it work”. The sheer increase in manual coordination efforts with pieces of a trial moving outside of the 4 walls of the traditional site is unsustainable in the current operating models. The ability to transition work remotely during COVID shutdowns was enabled through connected technology advancement, and highly predicated on having a pre existing digital footprint of existing work. Imagine if we tried to remain “remote” while typing reports on a typewriter and shipping the only copy of a doc across the country to be reviewed and then sent back…we would immediately go back to the collaboration that existed in office. Trials are highly manual and remain highly paper based….see the issue. 

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Quote from Guest on September 8, 2023, 11:52 am

Doesn't seem to be an organizational shit show per glassdoor and the limited chatter that got back to me personally. 

As a rule of thumb, i would take glassdoor comments and limited chatter with a grain of salt.

Source: someone who has first-hand experience at said company. 

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Most companies fail within 2 years. A great idea, coupled with a well funded enthusiastic founder can seem like a great idea, but running a business is hard work, and an entirely different skill set than running a clinical trials. It's rare to find someone who understands entrepreneurship and the industry. The fall out is to be expected. 

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Have people failed to notice that layoffs are happening all around us right now?  Not sure why so eager to dig into assumptions about one company.

Alphabet (Google) laid off over 6% of the workforce.  Same with Amazon and Microsoft. 

BMS has cut hundreds.  Pfizer has told the markets to watch for cuts in Q4. 

Biotech 2seventy laid off 40% this week  Infinity laid off 78% over the summer.

Vendors from Charles River to Thermo Fisher have all announced layoffs.

This plus tech investors made a shift to have their companies focus on profitability this year — and if revenue is limited because pharma is tightening the belt, then headcount has to go down. 

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Quote from Guest on September 8, 2023, 2:23 am

They probably have good enough leadership but venture capital from outside of clinical trials industry can be problematic.

When they give you money they expect you to spend it. There's pressure on startup leadership to project confidence in their growth potential and then pressure from venture capital to scale up to fulfil that potential. All in the while it's forgotten about actually delivering a good product/service that fits into a market need.

It goes like this:

Tech VC: Health is a big market, want some money?
DCT startup: Sure, gimme
Tech VC: You have money, go and hire everyone and spend the money, grow quickly just like Facebook did! Coz all tech companies work like that and you are a tech company.
DCT startup: Sure, I can bring on 50 people to go out and sell our half-baked solution; let's grow!!!
Tech VC: Why aren't you growing fast enough?
DCT startup: Because the industry moves slow
Tech VC: Well why did we spend all that money?
DCT startup: Because you told me to
Tech VC: 😬
DCT startup: We're going to run out of money in 3 months
Tech VC: Here's another $2M to ensure you don't fail and we look bad. Don't tell anyone. Fire 70% of your team and cut costs until we can find another sucker VC to bail you out.

The scary thing with this approach is that it works 1/30 times in tech and that is enough to pay for the other 29 failures. I'm unsure if this translates to clinical trials...

Source: I have worked in venture capital-backed startups for 15 years and one in the clinical trial space for the last 3.

Yup.  That is pretty accuracy 

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