Oncology CRO Services Built for Complex Trials
Oncology trials are operationally distinct from most therapeutic areas. Protocol amendments are frequent, patient populations are narrow, safety monitoring is intensive, and the regulatory environment moves quickly. A CRO partner that performs well in cardiology or metabolic disease does not automatically translate to oncology — the margin for operational error is too small and the scientific context too specific.
Sitero is built for this. Across 200+ oncology studies in 67+ countries, we have developed an operating model that combines full-service clinical delivery with an integrated eClinical technology platform. The result is fewer handoffs, better site coordination, and cleaner data — which matters when your endpoints are complex and your timelines are tight.
Full-Service Oncology Capabilities
Our oncology capabilities span the full trial lifecycle. On the services side: study startup and site activation, clinical monitoring, patient recruitment support, medical monitoring, endpoint adjudication, and DSMB support. Biometrics covers data management, quality oversight, and biostatistics for complex oncology endpoints. Our AAHRPP-accredited IRB handles protocol review, remote management, and committee operations. Drug safety and pharmacovigilance includes end-to-end case management, aggregate reporting, signal detection, and safety submissions.
On the technology side, the Mentor eClinical platform provides EDC, RTSM/IRT, eConsent, CTMS/eTMF, participant and site payments, and real-time reporting — all integrated under one system rather than stitched together across multiple vendors.
Measured Operational Outcomes
Sponsors working with Sitero on oncology programs have seen a 40% decrease in study startup timelines, a 54% reduction in administrative costs at the site level, and a 60% decrease in data management closeout timelines. Protocol compliance improved by 20%. These are operational outcomes that matter in oncology, where delays in startup or data quality issues at closeout carry real program consequences.
Oncology Trial Designs We Support
Modern oncology development has moved well beyond single-arm, single-indication studies. We support biomarker-driven patient selection and precision oncology programs, adaptive trial designs that incorporate interim data, basket trials evaluating a therapy across multiple tumor types, umbrella trials testing multiple therapies within a single indication, combination therapy trials, and multi-arm designs. Each of these requires operational discipline and technology that can flex as the protocol evolves.
Who We Work With
Oncology sponsors typically come to Sitero when they need broad functional coverage without managing multiple vendor relationships, when they want clear ownership across clinical operations, safety, governance, and data, and when they need global execution capability without adding complexity. We work with emerging biotechs running their first oncology study and established sponsors managing global programs.
Frequently Asked Questions
Yes. Sitero combines full-service clinical delivery — including operations, pharmacovigilance, IRB, and biometrics — with the Mentor eClinical platform, which provides EDC, RTSM/IRT, eConsent, CTMS/eTMF, and reporting under one integrated system.
Sitero supports a broad range of oncology designs including biomarker-driven and precision oncology trials, adaptive designs incorporating interim data, basket and umbrella trials, combination therapy studies, and multi-arm protocols.
Across Sitero’s oncology programs, sponsors have documented a 40% decrease in study startup timelines, 54% reduction in site administrative costs, 60% decrease in data management closeout timelines, and a 20% improvement in protocol compliance.
