Articles & Guides
Three Vendor Oversight Lessons Every Biotech Should Know: A conversation with industry leaders
This article draws from a conversation between Scott Sawicki (Senior Director of Strategic Sourcing and Vendor Management, Centessa Pharmaceuticals) and Sol Babani (Founder and CEO, Symbiosis Advisors), moderated by Peter Haessig (Head of Client Partnerships, Diligent Pharma). Together, they bring over 60 years of experience across Sponsor, biotech, and CRO organizations.
Vendor oversight is one of the most consequential functions in clinical operations, and one of the most inconsistently executed — particularly for biotech teams running trials without deep internal infrastructure. The frameworks exist. The regulatory expectations are clear. The gap between what looks good on paper and what holds up in practice is where programs run into trouble.
The three lessons below draw from a structured conversation between practitioners who have navigated Sponsor-CRO relationship management and Vendor qualification from both sides of the equation. The focus is on what rigorous, fit-for-purpose oversight actually requires.
The Sponsor-CRO Relationship Needs Active Management, Not Just Monitoring.
For biotech teams, the Sponsor-CRO relationship carries more weight than it does for large pharma. Biotechs with less clinical infrastructure are often running trials largely on CRO processes, expertise, and personnel — the CRO isn't just another Vendor, but an integral part of how their program runs.
A partnership can track green across every metric while the working relationship quietly deteriorates. Metrics capture outputs, but they don't capture whether the right people are aligned, and whether there's enough ownership on both sides to course-correct when things get difficult.
Practical Takeaway
Most biotechs don't realize they can ask their CRO for a dedicated senior relationship owner, even on a small or single-study engagement. Sol was direct on this:
"Don't be afraid to ask your CRO for that executive level person. Even if you're running one phase two study with that CRO, you likely have somebody that is responsible for managing portfolios in biotech companies that can be a real advocate for you within the CRO."
Match Your Qualification Process to the Risk.
Vendor qualification doesn't need to be elaborate to be compliant. For biotech teams operating with lean quality resources, that distinction matters. A fit-for-purpose approach means the depth and rigor of your qualification process should be proportionate to the size and risk of the Vendor relationship — not applied uniformly across every engagement. Treating every Vendor relationship with the same level of scrutiny wastes resources and pulls attention away from the relationships that need it.
Scott shared a risk-based approach that works well for his organization: a qualification questionnaire is sent, responses are analyzed, and a follow-up conversation happens if needed. An audit only comes into the picture once a Vendor is actively handling trial data, or when the scope and risk of the relationship warrants it. It's an intentionally lean model, and a legitimate and defensible one under ICH E6(R3).
Practical takeaway
Qualifying a Vendor through a questionnaire alone is a legitimate and defensible approach — provided the decision is informed by a clear assessment of the Vendor's risk and impact to the trial.
Beyond qualification, there's an important difference between governance, oversight, and micromanagement. Governance is the structure, the meetings and reporting cadence you put in place. Oversight is the active monitoring of whether the CRO is delivering what they committed to. Micromanagement is Sponsor involvement that undermines the CRO's ability to operate. As Scott put it:
"You're going to ask the CRO to do X, Y, Z — let them do their job. But have the correct oversight of that, because at the end of the day the Sponsor is responsible and accountable for the data that gets submitted to your health authority."
Qualification Is the Starting Point, Not a One-Time Checkbox.
Qualification data shouldn't sit in a file and only resurface when something goes wrong. If a questionnaire or early audit surfaces a gap, that information should directly shape where oversight is prioritized during the study. For biotechs running trials largely on CRO processes and procedures, a gap in CRO internal discipline is a direct risk to the Sponsor.
Practical Takeaway
One of the more common audit findings, and one most Sponsors don't anticipate, is CRO teams not completing their own SOP training. Asking about training compliance during qualification is a legitimate and practical part of any active oversight model.
Continuing the conversation
At Diligent Pharma, we advise biotech teams on how to streamline vendor qualification and build more mature, risk-based oversight programs. If your team is navigating any of the challenges covered here, we'd welcome the conversation. Reach out to Madhesh Desai at madhesh.desai@diligentpharma.com.
For more insights on Vendor oversight and the evolving Sponsor-CRO landscape, follow Diligent Pharma on LinkedIn.
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