CRO Selection & Governance for a Phase 3 Asthma Program

VRMM Stage: Pivotal Inflection

Summary

Avillion, a late-phase therapeutic project partner accelerating market availability, required guidance for CRO selection across two clinical trials.

With ambitious delivery timelines and multiple suppliers involved, Avillion needed both robust vendor selection and a governance framework to manage multiple CROs effectively.

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This organized, dedicated and enthusiastic team goes the extra mile to guide you to a final highly data driven decision, which meets your business needs and serves as a strong basis for the conduct and delivery of outsourced trials!

Anna Danilewicz

Vice President of Clinical Development

What Seuss+ Delivered

End-to-End CRO Selection & Supplier Governance Setup

Seuss+ managed the full vendor selection lifecycle while building a governance model for long-term supplier collaboration. By combining data-driven selection, diligent contract negotiation, and SOP-driven governance structures, we positioned Avillion for regulatory compliance and operational efficiency.

 

The Risk/Challenge

M

Multiple CROs requiring strong Master Service Agreements (MSAs) to ensure alignment

M

No existing multi-supplier governance framework

M

Risk of increased scope changes and inefficiencies without rigorous RFP and contract structure

M

Need to meet current and future regulatory requirements

The Results

N

Robust outsourcing process created, minimizing scope changes

N

CROs consistently over-achieved critical milestones

N

Significant cost savings achieved through contract negotiations

N

Fully documented CRO selection process, compliant with current and future regulatory expectations

N

New supplier governance framework improved efficiency, reducing meeting time and increasing oversight consistency

How We Helped

Negotiated MSAs with multiple CROs to protect sponsor-vendor relationships and ensure clarity upfront

Assessed team alignment and defined a selection criteria framework for cultural and technical fit

Managed full CRO selection process, from RFI to bid defense, including RFP creation and vendor shortlist

Conducted RFP contract negotiations, securing favorable terms and minimizing scope changes

Designed a multi-supplier governance framework, including SOP review, gap analysis, and integration of new tech platforms for oversight

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