“Clinical Research Organizations are the necessary evil” – these were the words of a new friend of mine working for a biotech company. He spent the last 20 years working for both sponsors and CROs and speaks out of his experience being in multiple roles including a monitor. Last month he had to visit a site and see how monitoring is being done and his next words were:
“We do monitoring almost like 20 years ago. Tell me another industry that hasn’t changed for this period of time.”
He is right… and wrong at the same time. First of all, the reason why CROs exist in the first place is the fact that very few companies out there can afford to maintain staff with the know-how in clinical research and fully dedicated to running their clinical trials.
Even companies that can afford that, still prefer to outsource their clinical operations to 3rd parties because their business is not in conducting trials, rather monetizing on the products they get validated through trials.
Why are CROs “evil”?
Many people like my friend would say that the goals of the sponsors and the goals of the CROs are misaligned. And looking at the traditional CRO business model for decades, this is true.
The more time the sponsor spends on their clinical trials, the more revenue for the outsourcing organizations. Yet, time for the sponsor means money and this is exactly what many biotech companies lack.
This is why a lot of CROs have decided to match their business goals and budgets with those of the sponsor by marrying their revenue to their success or getting a cut from their deals after approval which is an interesting model of partnership.
Why still this mistrust in CROs?
I will use another quote from another colleague from the industry: “We shouldn’t mix professional knowledge with operational capacity”. This quote refers to how many Clinical Research Organizations plan their clinical trials.
In reality, each CRO has its own “zone of comfort” which might be a Therapeutic area or Geographical coverage. In the ideal world, CROs would be able to have a super professional team that is capable of bringing processes in place to conduct trials as if it is almost manufacturing at scale.
This should bring efficiency and most of all better margins. We don’t live in the ideal world and each clinical trial protocol is too far from being “ideal” to be replicated, which means that CROs have to spend a lot more resources on each trial than they would feel comfortable with.
Going the extra mile with each project may be what sponsors expect, but it’s definitely not what CROs can afford, especially the big ones.
Is there a way to fix this?
Maybe…and this is where my question comes: “How do you imagine a virtual CRO?” and would that be the key to a customized approach towards each trial, yet, better return on investment for the CRO staff?
As a start, I would add an amendment here that I don’t believe that everything should become virtual, digital etc. Technology is about empowering human capabilities and making redundant processes more scalable and efficient. With that said I strongly believe there is a lot of room for virtualization of the existing model of Clinical Research Organizations.
There are things that can be completely replaced by machine learning and NLP technologies like for example the assistants work on documents related to sites, investigators’ CVs etc. In 2018 I was discussing this strategy with IQVIA and later I saw that Veeva is working towards such a solution.
This means that all the manual collection of sites documents, cross-checking and tracking can be replaced by a more efficient virtual process allowing at the same time more accurate outcomes.
Monitors (site visits was where the majority of CROs make their money traditionally) especially after COVID are next to be virtualized. In this case though we don’t speak about removing the role, rather changing its objective.
Monitors are the connection between the site and the clinical trial. If most documents at the site become digital (which is a trend in the last few years), then it does not make sense for CRAs to travel all the time just to collect the papers. All documents can be collected automatically, and not just collected but also checked, which will help CRAs to focus on their relationship with the investigators and study coordinators (and cover a lot more sites at the same time).
Can CROs change their business model?
One thing that I believe will make a huge impact is if the CRAs have the time and skills to identify what makes a site motivated and efficient when working on a trial and create processes to scale that across all sites selected. These insights are invaluable also for future clinical trials and might make the site identification and surveying a lot more simpler than it is now too.
What is important to mention here though is that by changing the role of the monitor, this requires changing the business model of the CRO too. Something that will definitely make the clinical research industry a lot more efficient (if we speak about its mission – bringing drugs faster on the market).
Maybe a more virtualized CRO will have fewer expenses on hiring and keeping people which will contribute to better margins. At the same time, CROs budgets can be aligned with the milestones of each clinical trial and get compensated for overdelivering too.
I am sure with some smaller biotech companies the revenue/risk share type of business model might be also an interesting strategy to get compensated though it is a long-term strategy.
Regulatory advisors on-demand?
Having a regulatory team in each country will make no sense any more. Our TrialHub experience with local advisors shows that if you need consultation or even assistance with the regulatory authorities you can also use independent consultants. And the best part about it is that they will always come with the specific know-how in the type of trial instead of relying on 1 or 2 people to know everything at glance.
You can read our success story with diagnostics which is a great example of how in a dynamic regulatory landscape (maybe you’ve heard about the new regulatory requirements in regards to medical devices and diagnostics) when you can not rely on your past experience, local people with the right background can help you out.
For the past 2 years, our team has been working on over 1000 clinical trials, mainly led by CROs and in many cases our job was to suggest new to their experience countries. We’ve learned that if you have the right leadership at the CRO and experience in running studies, you can easily manage people remotely without having to hire them in the first place.
In a nutshell, virtual or not CROs need to change not only because our ecosystem requires that but also because all other industries evolve and competition increases. I see a huge trend of CROs being led by people with a technology-background who bring a different perspective and hopefully will introduce some of the enhancements from other industries into clinical research too.
So I wonder, how do you imagine a virtual CRO?
Are you looking to expand your company’s ‘comfort zone’ into new therapeutic areas or geographical regions? Our 2021 clinical research market overview can give you a perspective over the therapeutic and geographical areas least affected by the pandemic as well as TAs booming in 2020 and Q1 of 2021.