This old Russian proverb — which entered the American lexicon during Reagan’s talks with Gorbachev in 1986 — presents an open challenge to the clinical research industry. It translates to trust, but verify. While we might trust the integrity of the data our studies generate, rarely do we actually verify it in alignment with the FDA’s ALCOA guidance.
This excerpt from a recent Arizona State University study on sample integrity drives the point home:
Biological samples are ground zero in the quest for dependable science, yet researchers hoping to publish their work may have a disincentive to spend the time to probe the integrity of their specimens — There is a danger of an ignorance is bliss mentality.
Do you have the systems and safeguards in place to ensure every sample (across all of your labs and biorepositories) maps to specific patients for specific sites for specific time points?
But questions surrounding the integrity of our clinical data are just a part of a big, bad storm that’s been brewing for far too long.
Clinical trial sponsors rely on efficient study design and execution to get their products to market on time and on budget. Increasing protocol complexity, stakeholder interdependence, and operational inefficiency not only impact data integrity, they also significantly delay time to market for countless drugs and devices.
These costly delays impact 85% of clinical trials, driving revenue losses that range from tens to hundreds of millions of dollars. Earlier stage studies — with fragile single digit success rates — are especially susceptible to friction-induced collapse.
~ Pardon me real quick while I reach over and grab my soap box. ~
I am just as EXHAUSTED by (1) the lamenting of the ECONOMIC impact of clinical trial delays as I am by the ABSURDITY that (2) systemic delays have become the status quo for an industry so focused on corrective action through innovation.
Before the global pandemic, back when in-person conferences were still a thing, I’d walk the halls of vendor booths and sit in those incredibly uncomfortable chairs that seem to be a staple of every session talk and just listen.
The message was the same:
But the truth always lies behind the shiny veneer of marketing promises. And the hard truth — that everyone is ignoring — is that we’re consistently failing our patients. Patients who, as a result of insufficient healthcare options, must often rely on clinical research as a care option.
Why does it have to be this way?
I’ve got an answer, but it’s one that you’re not going to like because it probably hits a little too close to home. Most people who work for sponsors, CROs, vendors, and labs haven’t actually spent much time interacting with patients at Research Sites. Have you ever visited a Research Site?
We definitely have.
Slope’s team includes former Trial Managers, Study Coordinators, and Lab Techs. We’ve visited countless Research Sites and have worked with thousands of Study Coordinators around the world to help them track, organize, and manage all of the drugs, devices, kits, samples, and equipment that are necessary to move clinical research forward.
And we’ve witnessed a lot during this process:
We’ve seen — over and over again — how patients are the ones ultimately impacted by poorly designed and executed clinical supply chain management strategies.
I’ve got a promise to make, and it’s a promise that goes back to the very first line of this blog post. I want you to trust — but verify — everything I’ve said above.
I then want you to decide if you’re fine with of all the “patient-centric promises” that are never delivered. I want you to decide if you’re truly tired of managing all the ClinOps chaos that attacks your inbox every morning and keeps your team behind schedule. I want you to decide if you’re really OK with a vendor management strategy that’s based entirely on anecdotal evidence.
I’ve got some good news for those of you who are fed up with the status quo. I’m going to make you a promise that no one else in our industry has ever made, or possibly could deliver on.
Because when it comes to ClinOps, boring is better. Boring means fewer surprises for you, your vendors, your labs, your sites, and most importantly, your patients. You see — it’s impossible to have a truly patient-centric study without having a patient-centric clinical supply chain management solution serving that study.
I get asked all the time what Slope is, but I want to start by saying what we’re not.
We’re not a better EDC, CTMS, IRT, or RTSM, nor are we a better version of the outmoded CRO model.
Slope’s solution represents an evolution — a patently different approach — to attacking the growing complexity, interdependence, operational inefficiency, and data integrity issues that are plaguing today’s modern clinical trials.
Our data-driven, highly structured approach to clinical supply chain management delivers order, trust, and predictability, helping your clinical trial stay on track while delivering impeccable data integrity.