Early Phase Oncology CRO
Expertise in all aspects of early clinical development in oncology
The rise of precision biologics is redefining early phase oncology, raising the bar for innovative, adaptive clinical trial design and execution that will make patient-centered dose escalation and optimization more efficient and facilitate better, faster decision making.
Our early phase oncology experts apply extensive global experience in developing new treatments for all aspects of early phase oncology using the newest technologies and methodologies.
Proven leadership in phase I oncology trials
Over the past 5 years:
>300
early phase oncology clinical studies
>5,000
sites worldwide across a range of indications and mechanisms of action
>28,500
participants
Meeting you where you are with right-sized solutions
We partner with companies of all sizes, offering you:
- Deep scientific expertise: Access to specialized early phase oncology experts (medical/scientific, biostats) with experience in all aspects of early phase oncology—from dose escalation through optimization and expansion—characteristic of a boutique early phase oncology CRO.
- Operational flexibility & efficiency: Streamlined processes, dedicated team, and a focused early phase oncology site network to accelerate study timelines and reduce burden on sites and patients, backed by the capabilities and resources of a large early phase oncology CRO.
In the last 5 years:
225
biotechnology companies
49
large pharmaceutical companies
36
small/midsize pharmaceutical companies
Leading Early Phase Clinical Trials for ADCs and Radiopharmaceuticals: Expert CRO Services for Next-Generation Cancer Therapeutics
The rapidly evolving landscape of oncology therapeutics has positioned antibody-drug conjugates (ADCs) and radiopharmaceuticals at the forefront of precision cancer treatment. As these innovative modalities advance from bench to bedside, the complexity of early phase clinical trials has intensified, requiring specialized expertise in protocol design, regulatory navigation, and safety monitoring. Our CRO brings decades of experience in managing first-in-human and dose-escalation studies for these sophisticated therapeutic platforms, understanding the unique challenges that ADCs and radiopharmaceuticals present in Phase I and Phase II trials.
From managing complex dosing regimens and monitoring for novel toxicity profiles to coordinating specialized imaging requirements and radiological safety protocols, we provide comprehensive support that ensures both patient safety and regulatory compliance while accelerating time to market.
Why Syneos Health for early phase oncology?
- Our early phase oncology capabilities are anchored in a dedicated Center of Excellence, offering advanced training, SME coaching and a collaborative network to ensure expert-led oncology clinical trials.
- We deliver adaptive trial design excellence via our Biostatistical Consultancy Group, using Bayesian optimal interval and Bayesian logistic regression models to optimize strategy.
- With FDA-endorsed dose optimization methods, we accelerate development by balancing efficacy and tolerability.
- Our global reach and strong local site relationships, including our Catalyst Site Network, boost patient recruitment and streamline execution.
- From startup to data delivery, we align with your goals, ensuring precise cohort management, real-time insights and enrollment control.
- Every solution is fit-for-purpose—flexible, scalable and powered by our Trusted Process®.
Driving Actionable Insights in Early Phase Oncology
Our experts share how adaptive trial strategies and real-time insights are redefining what's possible in the early phases of oncology research.
Let’s talk about your next early phase oncology clinical trial.
The primary goal of a phase I oncology clinical trial is to assess safety, tolerability, and determine the optimal dose. Unlike other phase I trials, oncology studies often include patients with advanced cancer rather than healthy volunteers, and they may also provide early signals of efficacy. This is because the treatments being tested are intended to target life-threatening diseases and may offer potential benefit even in early stages of development.
Phase I oncology trials face unique challenges not typically seen in other therapeutic areas. Enrolling patients with advanced, treatment-resistant cancers can complicate recruitment. These studies often involve novel agents that may cause severe or unpredictable side effects, requiring intensive monitoring. Trial designs are typically more complex, incorporating adaptive dose-escalation and biomarker-driven cohorts. Additionally, because participants often have limited treatment options, there’s greater urgency and ethical responsibility in trial design and informed consent.
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