Driving Clinical Trial Success in CNS – Pivotal Phase 3 Study
Summary
A privately-owned clinical-stage biotechnology company, focused on developing therapies for CNS indications, faced the high-stakes challenge of running a pivotal Phase 3 clinical trial for its lead asset.
Partnering with a small CRO experienced in the disease area but inexperienced in complex global trials posed significant risks to operational delivery and future asset value.
Seuss+ was engaged to optimize vendor alignment, governance, and inspection readiness to ensure trial success.
I cannot imagine NOT having Seuss+ as part of our business, to be honest. For a scaling company such as ours, there are vendors who can give you every piece. But being able to maintain the relationships and understanding of our company, and provide solutions, is something that Seuss+ excels in.
What Seuss+ Delivered
Structured Vendor Oversight & Governance Across the Trial Lifecycle
Seuss+ embedded robust governance, strengthened vendor performance, and ensured the sponsor had clear visibility and control across all operational layers.
The Risk/Challenge
Small sponsor team at a critical clinical milestone with high strategic stakes
CRO lacked global trial execution experience
Complex outsourcing landscape with multiple vendors and subcontractors
Risk to future asset value if operational processes were not optimized
The Results
Improved CRO accountability and performance, reducing operational delays
Governance structures provided board-level visibility and risk confidence
Strengthened sponsor-vendor collaboration, ensuring alignment across multiple vendors
Achieved inspection readiness ahead of submission, with no critical findings reported
Supported the sponsor in maintaining milestone timelines and asset value protection
How We Helped
Supplier Framework & Contract Negotiations: Structured contracts aligned with strategic objectives, streamlining processes and reducing risks.
Risk Management, Governance & Reporting: Installed governance structures and reporting pathways to manage risks across vendors.
Clinical Systems Analysis: Reviewed CRO systems to recommend data integration, flow efficiency, and compliance improvements.
Vendor Oversight & Management: Provided global oversight of CRO and CDMO operations, including subcontracted vendors.
Sponsor Team Dynamics: Applied PI index to strengthen team collaboration and decision-making across sponsor and vendor teams.
Inspection Readiness: Ensured compliance ahead of submission through inspection-preparedness reviews.
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