Executing Biomarker-Driven Oncology Trials with Operational Precision

The shift toward precision oncology has fundamentally changed how oncology trials are designed and run. Biomarker-driven patient selection — identifying eligible patients based on genomic, proteomic, or other molecular characteristics — introduces operational complexity that generalist CRO models are not built to absorb efficiently.

Sitero supports precision oncology programs through an operating model built around biomarker integration from protocol design through data closeout.

The Operational Complexity of Biomarker Eligibility

When patient eligibility depends on a biomarker result, the trial’s enrollment funnel narrows considerably. Every step between tissue collection, central lab testing, result return, and enrollment decision is a potential source of delay. Sites need clear procedures and responsive coordination to move eligible patients through this sequence without losing them to competing trials or disease progression.

Sitero coordinates with central laboratories to manage biomarker testing logistics, establish result turnaround expectations, and ensure sites have what they need to act on eligibility data quickly. We build these workflows into study startup rather than trying to retrofit them mid-study.

Biomarker Data Integration

Biomarker data — whether from central labs, local labs, or companion diagnostics — needs to flow cleanly into the trial dataset. This means EDC systems configured to capture biomarker results accurately, with appropriate edit checks and data review logic built in from the start. Sitero’s data management team designs these specifications for oncology endpoints, not adapted from a generic template.

Site Selection for Narrow Eligibility Populations

Finding biomarker-eligible patients requires sites with the right patient populations and diagnostic infrastructure. Sitero’s site selection process for precision oncology programs accounts for site-level biomarker testing capability, patient throughput, and prior experience with genomically-selected populations. This reduces screening failures and protects enrollment timelines.

From Biomarker to Endpoint

For sponsors developing therapies with a companion diagnostic or biomarker hypothesis, the data generated during the trial needs to support both the regulatory submission and the scientific story. Sitero’s biometrics team supports biostatistics and data management for biomarker-stratified endpoints, ensuring the analysis dataset reflects the precision of the trial design.

Operational Readiness for Precision Oncology

Precision oncology programs move quickly when the science dictates. Sitero’s model is designed to keep operations aligned with that pace — with biomarker workflows built in at startup, data specifications designed for genomically-stratified populations, and site selection that accounts for diagnostic infrastructure before activation. Across our oncology programs, this operational discipline has contributed to a 40% decrease in study startup timelines and a 20% improvement in protocol compliance.