We Strengthen Sponsor Governance in Outsourced Clinical Trials
Outsourced trials require deliberate governance and sponsors who are equipped to uphold it.
WE ARE SILVERTREE BIOLIFE
Silvertree BioLife is a clinical governance advisory firm focused on strengthening sponsor oversight in outsourced clinical trials.
As programs scale and execution is delegated to CROs, oversight can weaken without deliberate structure. Silvertree brings clarity and discipline to sponsor oversight, defining responsibilities, formalizing escalation pathways, and ensuring regulatory readiness is supported by evidence, not reconstruction.
We work with emerging and growth-stage biotech sponsors to align sponsor accountability with CRO execution so that trial conduct remains deliberate, structured, and defensible.
In lean organizations where clinical, quality, and operational roles often overlap, structured cross-functional engagement is essential to maintaining sponsor accountability.
OUR APPROACH
Effective governance is not incidental. It is built through structured assessment, intentional design, and sustained cross-functional engagement.
In outsourced clinical programs, clarity of responsibility and traceability of decision-making are essential. Oversight must be visible, escalation must be defined, and accountability must be documented.
OUR WORK FOCUSES ON THREE PILLARS
ASSESSMENT
ASSESSMENT
ASSESSMENT
We evaluate sponsor oversight structures, vendor accountability controls, and inspection readiness risk exposure to identify where governance can be strengthened.
DESIGN
ASSESSMENT
ASSESSMENT
We develop fit-for-purpose oversight frameworks and escalation pathways aligned with your program stage and operational reality.
ADVISORY
ASSESSMENT
ADVISORY
We provide sustained guidance as programs scale — ensuring sponsor accountability remains clear, documented, and defensible.
We were at a point where our CRO oversight needed more structure. Silvertree clarified responsibilities and helped us strengthen our approach to sponsor accountability.
— S. Campbell, Senior Director, Clinical Operations
As programs scale and CRO execution expands, sponsor oversight must remain structured, visible, and accountable. We help you ensure it does.
Silvertree BioLife
Clinical Operations | Quality Assurance