In early-phase oncology trials, what appears on the surface rarely tells the complete story. When a leading Phase 1-2 study evaluating an innovative bifunctional antibody encountered challenges, Precision's unique approach revealed how understanding hidden complexities through deep relationships could transform potential roadblocks into pathways for success. This case study demonstrates how moving beyond traditional CRO services to true partnership creates lasting value through relationship power and innovative problem-solving.
Uncovering the Real Challenge
What initially presented as standard operational hurdles—data cleaning delays, sample management issues, query backlogs—masked a more complex reality. At one of our highest-performing sites, Memorial Sloan Kettering Cancer Center (MSKCC), rapid enrollment success created unexpected pressures. The site's remarkable ability to identify and enroll appropriate patients led to a surge in data management demands that standard processes couldn't adequately address.
Through multiple relationship channels, our team discovered that apparent communication barriers between clinical and laboratory teams weren't simple gatekeeping issues. Instead, they reflected deeper resource constraints affecting the entire site ecosystem. The research team, managing multiple competing studies, found themselves overwhelmed by data entry demands. Meanwhile, a separate laboratory team operated in relative isolation, creating disconnects between sample collection and clinical data management.
Overall, the situation exemplified a common broader truth in complex trials: surface-level symptoms often mask systemic challenges that require deeper understanding and more comprehensive solutions. Standard escalation procedures and traditional monitoring approaches, while valuable, wouldn't address the root causes creating these pressures.
Our approach to root causes is proactive, not presumptive. At one point, one of our team members called the research manager and said, 'Hey, look, I'm just trying to understand what are the limitations here?' And so she was able to really kind of peel back the layer. Proactive and clear communication can change everything.
The challenge demanded more than operational fixes—it required understanding site dynamics, building bridges between isolated teams, and developing solutions that acknowledged real-world constraints while maintaining study integrity. This realization set the stage for a transformative approach to study management.
Relationship Power in Action
The power of relationships emerged as the key to unlocking sustainable solutions. The Precision Site Network (PSN) proved valuable far beyond its traditional role in enrollment, providing multiple channels for understanding and addressing complex challenges.
When standard communication paths hit barriers, particularly regarding laboratory team access, PSN coordinators leveraged different site relationships than study teams typically maintained. These connections, built through long-term collaboration, provided alternative pathways for problem-solving. Project managers, drawing on their clinical backgrounds, engaged in peer-to-peer discussions that revealed resource constraints underlying performance issues.
At MSKCC, this multi-channel approach proved transformative. When the research manager expressed frustration about query backlogs, our project manager's nursing background enabled a peer-level conversation that uncovered the true scope of their resourcing challenges. This understanding led to creative solutions, including exploring third-party data support options that could integrate with the site's existing processes.
Additionally, Precision's relationships with principal investigators provided another avenue for influence and problem-solving. When laboratory team access became critical for resolving sample management issues, PI relationships helped bridge gaps between clinical and laboratory departments, fostering collaboration instead of competition for resources.
We took that back to the contact in PSN... They have very intricate relationships with these PIs at these sites. That's the other piece of it. So, we lean on them to lean on their PI that they brought to the table.
Adaptive Problem-Solving in Practice
In this trial, understanding root causes enabled truly innovative solutions. Rather than simply escalating issues or demanding faster response times, the team developed adaptive approaches that addressed both immediate needs and underlying challenges.
The traditional data cleaning process, triggered by specific study milestones, proved inadequate for sites managing rapid enrollment. In response, the team restructured the approach, implementing rolling reviews for patients completing treatment. This change not only improved data quality but reduced pressure on site resources by distributing workload more evenly.
For sites facing resource constraints, we developed customized monitoring strategies that prioritized critical endpoints while maintaining study integrity. This included creating targeted monitoring approaches for RP2D decisions and establishing clear priorities for query resolution. The team worked with sites to identify critical data points, ensuring limited resources focused on the most important elements first.
Cross-functional communication protocols evolved as well. Regular touchpoints between clinical teams, laboratory services, and site staff helped prevent issues before they arose. When challenges did emerge, established relationships enabled quick resolution through collaborative problem-solving rather than escalation.
Building Solutions Through Partnership
The transformation from traditional CRO-site relationships to true partnership manifested in concrete operational innovations. When MSKCC's data entry backlogs threatened timeline adherence, our response went beyond simple escalation. Understanding their use of a third-party vendor (Three Wire), we explored integrating additional support within their existing infrastructure rather than imposing new processes.
What tends to work best when you're dealing with sites in these types of situations is having a goal that you can have them working towards, offering whatever support that we can provide them to help get them there. That's one of the ways Precision builds true collaborative relationships.
This collaborative approach extended to laboratory management. Rather than viewing lab access restrictions as obstruction, we leveraged PSN relationships to understand internal site dynamics. Through these discussions, we discovered that the lab team operated under different priorities and pressures than the clinical research team. This insight led to developing bridge processes that respected both groups' constraints while improving sample management efficiency.
The site monitoring strategy evolved similarly. Traditional approaches assuming uniform site capabilities gave way to customized plans considering each site's unique characteristics. At high-enrolling sites, this meant implementing parallel monitoring tracks - maintaining standard oversight while adding targeted reviews for critical data points. This flexibility enabled sites to maintain enrollment momentum while ensuring data quality.
Most importantly, these solutions emerged through dialogue rather than directive. Regular communication channels between Precision's team, site staff, and sponsor representatives created an environment where challenges could be discussed openly and addressed collaboratively.
Measurable Impact Through Understanding
The success of this relationship-powered approach manifested in both traditional metrics and deeper operational improvements. Phase 1 enrollment completed on schedule with 44 patients, with PSN sites contributing 50% of enrolled subjects - demonstrating the tangible value of strong site relationships.
Beyond these surface metrics, the impact of our adaptive approach became clear in operational efficiency. The restructured data cleaning process reduced backlog while improving quality. Sites reported greater satisfaction with monitoring visits, as customized approaches respected their resource constraints while maintaining study integrity. Laboratory sample management improved significantly once bridge processes were implemented.
Perhaps most tellingly, the relationship-driven solutions created lasting improvements in site performance. MSKCC, initially struggling with data management, developed more efficient processes that benefited not just our study but their overall research operations. The collaborative approach to problem-solving strengthened relationships, creating a foundation for future studies.
The Precision Difference
What truly sets Precision apart isn't just our ability to execute complex trials—it’s our understanding that successful trial management requires looking beyond surface challenges to address root causes through relationship power. This case demonstrates how our integrated approach transforms potential obstacles into opportunities for deeper partnership.
The PSN network provides more than just high-performing sites; it offers multiple channels for understanding and addressing complex challenges. Our project teams, combining clinical expertise with operational excellence, can engage meaningfully with sites to develop workable solutions. Most importantly, our commitment to true partnership means we approach each challenge as an opportunity to strengthen relationships and improve processes.
This comprehensive approach - understanding hidden challenges, leveraging relationship power, and implementing adaptive solutions - creates value that extends far beyond traditional CRO services. It builds lasting partnerships that improve current study execution while creating foundations for future success.
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