RMG introduction
Oliver Duke from our team met Steve Crow at a life sciences networking event. A follow-up call with Steve's co-founder, Matt Hersch, quickly turned into a conversation about working together.
Matt and Steve spent almost two decades at GW Pharmaceuticals. They joined when the business was in its infancy and stayed through its growth to the acquisition by Jazz Pharmaceuticals. Today, through BlueGreen Clinical, they support therapeutic biotechs with clinical operations across three continents.
Their story chimes with what we see on the hiring side. Early-stage biotechs move fast, and quality systems are often built around the work later rather than designed in from day one. We asked Matt and Steve what they find when they're brought in to fix that mid-flight.
Fixing the wings mid-flight by Matt Hersch and Steve Crow, BlueGreen Clinical
The request we get most often from biotech clients is help with their regulated processes: the SOPs and quality management system (QMS) that govern how a clinical trial is run. Sometimes we lead the first-time implementation. More often, we're asked to carry out a gap analysis on a system that's already in place, then fix what we find.
Those clients have, naturally, built their QMS without any input from us. And at the end of every gap analysis, we come to the same conclusion:
"It would have been so much easier to attach the wings to the plane when it was on the ground, rather than changing them once it's taken off and is in the air."
It's the old tradesman's principle of "right first time". It's also the thinking behind "quality by design", now built into Revision 3 of Good Clinical Practice (GCP), the international standard for the scientific and ethical conduct of clinical trials.
Some in our industry treat each new standard from the ICH, FDA, EMA, MHRA or TGA as another round in an arms race between sworn enemies. We've always seen it differently. Biotechs and regulators fundamentally want the same thing: new medicines that are safe, high quality, effective, and meet unmet medical needs.
Seen through that lens, SOPs and a QMS stop being a tick-box exercise or a necessary evil. They become the best way for a trial sponsor to make sure its results are safe and reliable (and, hopefully, statistically significant too). That's why regulators want them properly in place.
At GW, it was drummed into us that a reliable negative result is always better than a result, positive or negative, that can't be trusted. So we believe laying firm foundations, through robust SOPs and a sound QMS, is the crucial first step on any clinical trial journey. It's how you get a result that you, regulators, partners and potential acquirers can all trust.
The wings don't have to be perfect. But they do need to be fit for purpose, and fixed on tight, before you taxi, hit the runway and take off.
RMG's take
Matt and Steve's point applies just as much to people as to processes. The first QA and clinical operations hires a biotech makes tend to shape the systems everything else is built on. It's far easier to get those foundations right before the first trial than to rebuild them once it's under way.
If you're preparing for your first trial and thinking about who you need in place, we'd be happy to talk it through.
Matt Hersch and Steve Crow are co-founders of BlueGreen Clinical, which has supported therapeutic biotechs with clinical operations across three continents for nearly four years.
RMG editorial note:
This article forms part of RMG’s guest insight series, bringing perspectives from leaders, investors and advisers working across MedTech, life sciences and healthcare.
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