Oncology CRO Services

A biomarker‑driven oncology clinical trial uses molecular, genetic, or phenotypic markers to guide patient selection, cohort stratification, and endpoint interpretation. This approach improves signal detection, supports precision enrollment, and increases the likelihood that clinical outcomes are interpretable and relevant for regulatory decision‑making.

Precision for Medicine has executed 160+ biomarker-driven clinical trials.

Biomarkers help identify patients most likely to respond, reduce heterogeneity within study populations, and provide mechanistic context for efficacy and safety outcomes. In oncology, this enables adaptive designs, enrichment strategies, and more confident decision‑making across dose escalation, expansion, and registrational studies.

Precision for Medicine integrates biomarker strategy directly with clinical operations, specialty lab analysis, and regulatory planning to maximize development efficiency. 

Oncology trials employ a range of advanced designs including traditional dose-escalation Phase 1 studies, adaptive designs, basket trials, umbrella trials, and seamless Phase 1-2 and Phase 2-3 designs. Precision for Medicine has dedicated biostatistics and medical monitoring teams experienced across all of these approaches. 

Basket trials are most effective when a molecular target or biomarker is shared across multiple tumor types. Umbrella trials work best when multiple therapeutic approaches need to be tested within a defined cancer indication. Both require robust biomarker infrastructure, central lab coordination, and adaptive statistical frameworks — capabilities that Precision for Medicine provides through its integrated CRO and lab model. 

Precision for Medicine leverages its Precision Site Network of 100+ curated oncology-focused sites globally, including academic medical centers with access to rare tumor populations. For rare cancers, we combine targeted site selection with biomarker-driven screening protocols, digital patient engagement strategies, and investigator relationships developed over years of partnership.

Specialty labs provide the biomarker analysis, companion diagnostic development, and translational science that define modern oncology trials. Precision for Medicine operates 5 specialty labs supporting DNA, RNA, protein, cell, and tissue analysis with proprietary platforms including Epiontis ID and ApoStream, plus curated biospecimen collections that accelerate your translational program. 

Oncology drug development faces regulatory complexity including accelerated pathway navigation, companion diagnostic co-development requirements, and multi-regional submission coordination. Our team of regulatory and ex-FDA experts bring deep expertise to navigate your journey from IND through NDA/BLA submission.

An oncology‑focused CRO brings therapeutic depth, established site relationships, and regulatory familiarity specific to cancer research. This specialization supports better trial design decisions, more efficient enrollment strategies, and stronger alignment between clinical, translational, and regulatory activities as programs progress toward approval.

With 76% of our trials focused on oncology and 23 FDA and EMA approvals in the last 10 years, Precision for Medicine offers depth that generalist CROs cannot match.

Our integrated model connecting clinical operations with specialty labs and regulatory consulting eliminates the coordination gaps that delay oncology programs.