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December 11, 2020

Don't Get Bit

by
Ethan Seville

It’s 4:45 PM on a Friday and a CRA gets a call.

One of their Research Sites is scrambling. They have a patient coming in on Monday, and just discovered that all of the kits they need for a critical baseline visit are expired.

The Safety Review Board is meeting right after this visit, and there’s no time to reschedule. The CRA drops everything to call each of her other sites to see if anyone can overnight a baseline kit.

Sound familiar? It does to me.

I was the Research Coordinator at that site, and was just two weeks into my new job. The study I was working on had a ‘routine’ shipping delay — the kits had been ordered over a month prior, but no one at my site (or the CRO) had any idea because they had never been alerted.

If you’ve been in research long enough, you know exactly what it feels like when the panic sets in.

You scramble to answer these two questions:

  1. How can I fix this?
  2. Why did this happen?

For better or for worse, clinical researchers have gotten really creative at answering that first question.

As for myself, I ended up driving two hours to another site that happened to be participating in the same study. I was lucky. All it cost me was a four-hour round trip to ensure that our site would have what we needed. Unfortunately, not every ‘panic-moment’ works out this well.

Ask around, and you’ll find that almost every person in our industry has had their own ‘panic-moment’. Project managers scramble to chase down missing PK samples months after collection. CRAs scramble to find out why labs didn’t process irreplaceable patient samples within stability. CTMs scramble to figure out why the courier didn’t document any of the required information for sample transport. Coordinators scramble to keep everything together for multiple protocols simultaneously.

It’s a wonder that the whole industry hasn’t fallen apart.

When I realized just how prevalent this problem was, I couldn’t help but ask myself a slight variation of the second question above over and over again:

Why does this keep happening?

The answer is actually pretty simple. Guiding documents are often created by people who’ve rarely (if ever) stepped foot in a clinic. The ‘panic-moments’ that happen every day at Research Sites around the world are the product of unaddressed operational risks that inevitably arise from these blind spots.

I’ve worn every hat that you can imagine throughout my career in clinical research (Coordinator, Site Manager, Project Manager, and now Solutions Architect). I’ve lived through hundreds of protocols, pharmacy and lab manuals, amendment after amendment — all of them were infested with significant operational risk.

These points of operational risk are like venomous snakes — coiled, hidden in the grass, waiting to strike when you least expect it.

It was clear that our industry desperately needed a new perspective on trial design, framed from the standpoint of operational risk. That’s why I worked with Slope’s team of clinical research experts to develop the industry’s first Clinical Operations Business Risk Assessment (aptly abbreviated as COBRA). The COBRA proactively identifies, addresses, and mitigates the exposed risk in clinical trials.

I wanted to do everything I could to stop the 4:45pm-on-a-Friday-panic-moments. I wanted to make sure no coordinator ever got ‘bit’ by these preventable failures.

Clinical researchers are good at mitigating risk. Our industry is built around minimizing risk — for study participants. And yet, the clinical research machine has a major, glaring flaw:

Operational risk points are repeatedly overlooked and underestimated in study design, creating downstream issues for study participants while negatively impacting enrollment and retention.

When you proactively remove operational risk, your study becomes boring. Boring clinical trials are better clinical trials. Slope’s COBRA helps make your study boring by pinpointing hidden operational risk across five different categories:

  1. Site Resupply & Inventory Management
  2. Sample Collection, Processing, and Shipping
  3. Investigational Product and/or Managed Devices
  4. Supply Chain Visibility
  5. Clinical Data Integrity
Request a COBRA

Slope’s Clinical Operations Business Risk Assessment is an invaluable tool that helps you proactively reduce risk exposure while improving patient centricity. For me, that means no more ‘panic-moments’ spent driving across Atlanta in rush hour traffic to pick up a lab kit.

Our team at Slope is passionate about making clinical trials boring. The first step for you on this journey toward boredom is clicking the button below to request your very own COBRA.

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