Oncology Study Startup: 40% Faster Site Activation
Study startup is where oncology trials are won or lost. Delays in site selection, contract execution, IRB approval, and site initiation training compound quickly in oncology, where competitive enrollment and patient access to other trials make every week of startup delay meaningful.
Sitero’s oncology programs have achieved a 40% decrease in study startup timelines. That outcome reflects a specific operational approach, not a general commitment to speed.
Site Selection for Oncology Programs
Not all clinical sites perform equally in oncology trials. Sites need established oncology patient populations, diagnostic infrastructure aligned with the protocol’s eligibility requirements, experienced investigators with relevant disease area background, and the operational capacity to manage a complex protocol alongside their existing workload.
Sitero’s site feasibility and selection process evaluates these factors explicitly. For biomarker-driven trials, we assess site-level biomarker testing capability and central lab logistics before committing to activation. For trials with narrow eligibility, we prioritize sites with patient throughput data in the relevant tumor type rather than relying on investigator estimates.
Parallel Processing of Startup Activities
Study startup involves multiple parallel workstreams — regulatory submissions, contract and budget negotiation, IRB review, site initiation training, and supply setup. In a traditional sequential model, each step waits for the previous one to complete. Sitero manages these workstreams in parallel where possible, with clear ownership and milestone tracking that identifies delays early rather than discovering them at the target activation date.
Site Initiation and Training
Oncology protocols require thorough site initiation training, particularly for studies involving novel agents, complex eligibility criteria, or unfamiliar procedures. Sitero delivers site initiation visits and remote training that prepare site staff to enroll the first patient confidently.
Technology Readiness as Part of Startup
For sites using Sitero’s eClinical platform, technology readiness is built into the startup process. EDC build, RTSM configuration, eConsent setup, and user provisioning are coordinated with regulatory and contractual milestones so that technology is ready when the site is — not two weeks after activation. This integration is a direct contributor to the startup timeline reductions Sitero’s oncology programs have achieved.
Measuring Startup Performance
Sitero tracks startup milestone performance — from first site contract executed to first patient enrolled — across its oncology portfolio. This data informs site selection decisions, contract negotiation benchmarks, and activation timeline projections for new programs. Sponsors working with Sitero have visibility into these benchmarks before the study begins, so startup timeline commitments are grounded in documented performance rather than estimates.
Frequently Asked Questions
The reduction comes from parallel workstream management — running regulatory submissions, IRB review, contract negotiation, and technology setup simultaneously rather than sequentially — combined with targeted site selection that prioritizes sites with confirmed patient access and operational readiness.
Sitero’s feasibility process assesses site-level patient throughput in the relevant tumor type, biomarker testing infrastructure, investigator experience, and site operational capacity. For biomarker-driven trials, we evaluate central lab logistics before committing to activation to protect enrollment timelines.
EDC build, RTSM configuration, eConsent setup, and user access provisioning are managed in parallel with regulatory and contractual startup milestones, so technology is ready at site activation rather than on a separate delayed timeline.
