Remember, you can hire a contractor to build the house — but you're the one who has to live in it. Go break some eggs.
👀 The Read
The CRO doesn't own your study.
YOU do.
There's a quiet assumption that once you've picked a good CRO, the study is handled. They're the experts, they run these every day — they'll design it, run it, send the report, and you're done. So the protocol arrives, it looks professional, and it gets signed.
That’s great because in early-stage biotechs with small teams, that means less on your plate to deal with. But, that’s also wrong.
CROs don’t have skin in the game like you do. As the Sponsor, that is your study, your data, your animals, your NOAEL that supports your human starting dose that you have to defend to the FDA.
Let’s start with the study design. CRO designs are templated, optimized for their throughput, their equipment, their defensibility, the generic case. It's not built around your molecule's liabilities or your regulatory strategy. They don't know your compound the way you do.
Then the study runs. This is the part teams underestimate the most. A tox study cannot be George Foreman’d — you can’t just “set it and forget it”. Sponsors have to have ownership of the decisions made in-life, for instance if animals need to go down or doses need to be adjusted. Those decisions are always conversations with the CROs, but as the Sponsor, you own the consequences of them in the end.
Finally, we get to interpretation. This is where it matters most. What counts as adverse. Where the NOAEL lands. How a borderline finding gets characterized. The Study Director is responsible for that study including the adverse calls and NOAEL, but again, it needs to be a conversation with the Sponsor. At the end of the day, you are the one who will be authoring the IND that justifies the human starting dose that’s based on the NOAEL that’s based on the study data.
Think of the relationship with your CRO less as a handshake, and more as a hug. This is a partnership. And at the end of the day, you are the one who will need to answer for that partnership to the agencies deciding whether your molecule lives or dies.
Own your study accordingly.
The Misconception: A good CRO will design a study, run it and hand you the report with everything you need in it.
The Correction: A CRO runs your study; it doesn't own it. As the Sponsor, it's your data, your animals, and your NOAEL — the design has to align with your nonclinical and regulatory strategy, and you have to have input on the in-life, data, and reporting decisions. The CRO has no skin in the game when it comes to the FDA. That study is yours to defend.
🎓 CRO Management is Module 11 in my course
How to choose and outsource to CROs, the Sponsor-CRO partnership, study monitoring and oversight, managing CRO problems and changes and even a downloadable CRO Site Visit Checklist — all covered in The Complete Guide to Nonclinical Development.
Use code WELCOME50 for $50 off:
