Driving Operational Efficiency in a Respiratory Trial with Legacy CRO Constraints
Summary
A clinical-stage biotech in Phase 2 development was navigating early clinical demands while managing lean internal resources. With a large global CRO already contracted under legacy terms, the sponsor faced operational inefficiencies, unclear cost structures, and limited financial transparency, putting strain on timelines and internal decision-making.
The sponsor sought expert support to optimize oversight, ensure adherence to contractual obligations, and strengthen structured governance processes without disrupting study continuity.
Invoicing error identified and corrected
In device and systems used to collect primary end-point data
Supporting contractual adherence and issue escalation
What Seuss+ Delivered
Ongoing Oversight, Financial Governance & Issue Resolution
Seuss+ provided embedded strategic support to manage vendor complexities mid-trial, offering clarity and control during a critical period of financial discrepancy and scope change. Leveraging our vendor relationship methodology, we enhanced governance structures, enforced contract adherence, and enabled the sponsor to regain financial and operational confidence with a large global CRO.
The Risk/Challenge
Legacy CRO contract entailed a complex approach to billing, which was error-prone and inconsistent in its adherence to contract terms.
£450K in invoice errors due to CRO system mistakes and poor invoice reconciliation.
Loss of primary end-point data, and secondary safety data, resulted in extension of recruitment timelines in order to recruit more patients to ensure number of completes needed for the analysis was achieved.
Limited internal capacity to manage vendor finance and operational oversight.
High risk of escalating CRO costs without strategic intervention.
The Results
Financial exposure minimized through strict adherence to contract terms.
£450K in CRO invoice errors identified and corrected, ensuring adherence to contract terms.
CRO governance strengthened; escalation pathways and oversight in place (including strong oversight documentation) .
Sponsor empowered to make informed financial decisions with clarity and confidence.
Study timeline extension minimised, with partial CRO financial accountability negotiated for such extension.
How We Helped
Partnered with sponsor leadership to define negotiation strategy and prepare documentation for CRO change-in-scope
Led multi-stakeholder resolution of £450K in financial discrepancies, coordinating across CRO finance, billing, and operations
Provided clear oversight structure to support and embed accountability across workstreams
Introduced contract controls and clarified financial terms to protect against future overbilling
Acted as a trusted operational advisor to a transitioning clinical team, maintaining study continuity during key changes
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