Why the CRO model for medical device clinical trials is broken and how to fix it

Who said: ‘If you are not part of the solution, you must be part of the problem’?

This appears to be a misquotation of Eldridge Cleaver  author of the 1968 book “Soul on Ice” and early leader of the Black Panthers. The correct (full) quote is: ‘There is no more neutrality in the world. You either have to be part of the solution, or you’re going to be part of the problem.

“CROs play a crucial role in operating clinical trials and meeting milestones. However, effectively managing CROs by having continuous visibility on their work and the quality of the data they provide remains a large concern for Clinical Operations executives. ”

This is a quote taken from a marketing email from Comprehend – a cloud software company that is focused on central monitoring. They’ve developed outstanding software; I’m on the mailing list and I enjoy reading the customer success stories.

Onsite monitoring performed by CROs accounts for 20-30 percent of total study cost and delivers 1-2 percent actionable items. Calling the quality of the data they provide a large concern for Clinical Operations executives is an understatement.

If data security worked like this – IT managers would be paying outsourcing companies like HP and IBM 20-30% of their total IT budget for monitoring their network which in return would result in only 1-2% actionable intelligence.     I don’t think so.   There is not a single IT manager in the world that would accept such abysmal performance at such high prices.

Hmm.   So let me get this straight.

CROs are delivering abysmally low-quality service – yet we are calling this an oversight and visibility issue.

Why? Why should we paper over a broken system with software?

The CRO business model is broken.

Where entire industries have undergone business process re-engineering over the past 30 years – clinical trials operations are stuck in the 80s with goofy/manual onsite monitoring and sponsors are being held hostage by CROS. This is reminiscent of the IT service bureau model of the 70s and 80s which evolved into software as a service for anything model of today.

Several years ago – our business unit that specializes in medical device security in Israel had engaged with a client running a large multi-center trial. We had a lot of interaction with the CRO and when I asked the CRO General Manager  (rather naively I  suppose) why they were not doing remote monitoring of data from their EDC system – she told me that she had given a talk about RBM at a conference the previous year but she didn’t seem to have a good reason for not actually implementing RBM with this particular study that had 30 hospitals in the trials

I pondered on the reason for that and realized that human, manual, onsite monitoring was an incredibly lucrative business for them.  They had no economic incentive to use better technology.  Good for the CRO. Bad for the sponsor that pays high prices and gets low-quality results.

Oversight is not a replacement for re-engineering the system.

CRO oversight is not a replacement for re-engineering the system which I believe will require more than oversight dashboards.   As we wrote here, communications with the sites is a critical component relating to a study’s performance and ultimately, its success.  In addition, cloud remote monitoring technologies and dynamic methods of risk assessment can help improve safety and get results faster by saving avoidable rework after data lock.

Productivity tools must result in better prices and results.

Good quality data with real-time alerts and collaboration that help teams work better together are great productivity tools that should enable the CRO to deliver much higher quality results at much lower prices.

15 years ago I was a business unit manager at a large group of companies.   One of the General managers pitched the CEO of the group with an idea to create cross-functional groups, share high quality data and improve collaboration to help teams work better together.

The CEO said – “The best synergy is when each person does their job”

If  sponsors told their CROs that their target is to reduce their monitoring prices by 50% and improve their rate of acquiring actionable intelligence from the sites by 5X ( 5% instead of 1% should not be a challenge) the industry would start going through a phase transition.

Just the way FedEx, IBM and Amazon changed the way we do business today, it’s time that sponsors started standing up for better service and lower prices.

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