Clinical Operations in Early Stage Companies: Madness Takes its Toll

by | Apr 22, 2020 | Blog

I have had nine – count them nine – meetings with Clinical Operations leaders at small, early-stage biotechs in the last week.  After hearing what life is like when trying to usher an organization’s first pipeline products through the clinical trial process, a song got lodged in my head.  If you are “of a certain age” than this lyric is probably very familiar:

It’s astounding
Time is fleeting
Madness takes its toll
But listen closely
Not for very much longer
I’ve got to keep control

I was speaking to the CRAs, Directors of Clinical Operations, and Clinical Trial Managers about the software they choose and use, but what I actually heard was something different. I learned that clinical trial professionals in early-stage biotechs, pharma, and device companies get stuck in a time warp, and madness takes its toll.

Here’s the challenge:

“Please get this product or therapy through the clinical trial process.”

“No, you cannot hire a CRA; you need to do it yourself.”

“We will need clinical sites in South America, Europe, and Asia.”

“Make sure we are fully compliant and can stand up to any inspections and reviews. I know that is not your expertise, but you can learn that part, right?”

And don’t worry, if you fail it is just the jobs of the other 99 of us at the company that will go down.”

“Oh, and do it in a year because that is all the funding we have.” 

Congratulations, you have entered the clinical trial time warp, where time stops making sense. The place where there is not enough calendar time, resource time, people time, or project time to possibly get done what you need to do.

I was talking to clinical operations folks about the way that we at Agatha “sell” our software, which is that we do not sell it at all. Instead, we start every relationship with a pilot project, fully staffed by us and with onboarding, importing, and test cases, at no cost to the customer. Our philosophy is that we want prospective customers to experience our apps, and us, for a period of time in a realistic environment before we commit to each other. 

Sounds pretty good, huh? And my research calls last week confirmed that it is the right way to bring a new class of business apps for TMF and quality management to customers. The prospective customer reduces their risk — no need for references and ten demos if you can use the software for a month. And we get new customers who are a perfect fit for our apps.

However — and this was a big, ‘however,’ they also consistently told me that they did not have the time or resources to do a pilot project. They are understaffed and doing the job of three people already.

So I am trying to get people to work with us on a free pilot so they can see how they can save time, but they don’t have time. We are stuck together in a time warp…where madness does indeed take its toll. 

I learned that Clinical Operations people in early-stage companies have a tough job. They are the heroes in getting new drugs and devices to the patients who need them. They claw their way over obstacles to ensure that promising therapies get into the hands of doctors. And from my calls, I also learned that they are very nice people, though yes, perhaps a little mad. In a good way.

We did solve the problem, by the way. I tested with these folks a way that their total investment of time for their pilot project participants would be limited to eight hours, at most, over the project period. And it may be on Saturday mornings or after 5. But they agreed they can squeeze out that time if I commit the resources to aid and abet the process throughout the pilot. 

We will train, do “deskside” support, import a sample set of content…whatever it takes to enable them to get a deep and meaningful experience using our software.  At Agatha, we will invest a lot, while our prospective customer invests judiciously.  Because even in a time warp, they feel they can find a couple of hours a week to devote to improving their systems and processes.

The only way out of the time warp is to find ways to save time. And saving time is the key to the ultimate goal of clinical operations professionals – to keep control.

If you’re interested in learning more about our pilot program for Agatha, sign up here.

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