When managing concurrent Phase 1 oncology trials, sponsors need more than operational excellence - they need a partner who can innovate while maintaining quality across complex programs. This case study demonstrates how Precision's integrated approach transformed two challenging early-phase programs through innovative trial design and strategic partnership. The results showcase how sophisticated early-phase execution can accelerate development while supporting broader program success.
A biotech company sought a partner to manage two concurrent Phase 1 trials while navigating complex financial and operational demands. The studies included a selective anti-αvβ8 integrin monoclonal antibody blocking TGFβ activation and a Nectin-4 targeting ADC. When financial constraints required temporarily pausing one program, the sponsor needed more than just a CRO – they needed a strategic partner who could preserve momentum while adapting to changing priorities.
Early-phase oncology trials typically face enrollment challenges and timeline pressures. These programs added further complexity through:
The programs demanded specialized biomarker assessment, complex sample management, and innovative trial design approaches. When financial constraints required temporarily pausing one program, maintaining momentum while preserving institutional knowledge became critical.
Precision deployed an innovative approach integrating clinical operations with strategic consulting. Our team provided extensive protocol development support, implementing an industry-leading adaptive Bayesian design with backfill strategy. This design optimized dose selection while satisfying regulatory requirements, demonstrating our ability to advance complex trial designs in early-phase oncology.
The program's success stemmed from maintaining consistent teams across both trials, enabling seamless knowledge transfer when priorities shifted. Senior medical and statistical experts became integral members of the sponsor's development team, providing critical guidance during protocol development and regulatory interactions. This collaborative approach proved especially valuable when financial considerations required temporarily pausing one study to focus resources on the other.
Precision deployed an adaptive Bayesian design with backfill strategy, optimizing dose selection while satisfying regulatory requirements. This sophisticated approach balanced efficiency with scientific rigor, enabling accelerated decision-making while maintaining study integrity. The design incorporated real-time learning, allowing for dynamic resource allocation across programs.
Our integrated approach yielded remarkable results. Sites activated within 30 days of target, with enrollment reaching 250% of baseline projections by month five. The Precision Site Network demonstrated particular value, contributing 65% of enrolled patients and consistently outperforming other sites.
Laboratory services integration proved crucial for managing complex biomarker requirements. Our teams developed and validated critical assays for inclusion criteria while implementing enhanced sample management procedures based on cross-program learnings. This coordinated approach between clinical operations and laboratory services significantly improved operational efficiency.
The relationship evolved into a true partnership, with Precision's leadership team engaging directly with sponsor executives to provide strategic guidance beyond standard trial management. This included sophisticated data analysis supporting investor presentations, which contributed to securing $175 million in additional funding for the programs.
In early-phase oncology development, success requires more than meeting individual trial metrics. Our integrated approach demonstrated how strategic partnership creates lasting value through:
Our ability to rapidly adapt to changing priorities while maintaining quality and timeline adherence proved invaluable. When the sponsor needed to pause one study, our team preserved institutional knowledge and quickly redeployed resources, ensuring no momentum was lost when activities resumed.
This case exemplifies how Precision's integrated service model delivers value beyond traditional CRO relationships. By combining operational excellence with strategic insight, we help sponsors navigate complex development challenges while maintaining scientific rigor and meeting aggressive timelines.
Precision's ability to deliver truly integrated support across complex development programs stems from our commitment to combining operational excellence with strategic insight. Our approach ensures:
Our commitment to true partnership, demonstrated through consistent team deployment, strategic protocol development, and executive-level engagement, creates lasting value throughout the development process. This comprehensive approach, backed by the performance of our site network and laboratory services, positions Precision as an ideal partner for complex oncology programs.
Learn how Precision's collaborative approach can advance your development programs while maximizing operational efficiency and strategic value.