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Therapeutic Areas Medical Oncology & Radiology

Medical Oncology & Radiology

Advancing innovation in oncology and radiology requires precision, collaboration, and deep cross-disciplinary expertise. Devices in this space face some of the most complex regulatory and operational landscapes in MedTech, often bridging diagnostic, therapeutic, and interventional technologies.

Avania is a MedTech focused CRO with extensive experience supporting oncology and radiological device development across all phases, from feasibility to pivotal and post-market studies. Our customized workflows, flexible structures, and multi-disciplinary teams streamline the process, reducing risk and accelerating time to market for high-impact technologies.

With a proven record of success in Class III devices, multi-reader imaging studies, and global oncology trials, Avania provides the insight and operational excellence sponsors need to navigate this demanding environment with confidence.

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Navigating the Unique Challenges of

Oncology & Radiology Device Development

Device development within oncology and radiology presents a unique set of challenges, ranging from multi-agency regulatory oversight to the coordination of imaging, surgical, and therapeutic endpoints. Avania’s dedicated team specializes in solving for this complexity.

  • Regulatory Complexity: We have deep expertise across PMA and IDE pathways and hybrid submissions involving CDRH, CBER, and CDER. We understand when a 510(k) delivery system becomes an IND-governed therapy, ensuring complete compliance and strategic clarity.
  • Integrated Imaging & Endpoint Management: Our experts provide advanced experience in multi-reader, multi-case (MRMC) imaging studies, including design, reader training, and adjudication workflows.
  • Cross-Disciplinary Oversight: Avania has proven success managing oncology programs requiring coordination between surgical, radiological, and medical teams.
  • Generalist CRO Limitation: Traditional pharma-focused CROs lack the agility and device-specific expertise required in this field. Avania’s processes and people are built for MedTech, not retrofitted from drug development.
  • Operational Advantage: Our customized, robust workflows and multi-disciplinary site networks deliver the flexibility large CROs can’t match, reducing risk and keeping programs on schedule.

Unparalleled Expertise:

Meet Our Oncology & Radiology MedTech Veterans

The Avania Team Advantage

At Avania, oncology and radiology studies are led by senior professionals with firsthand experience in device and diagnostic innovation. Sponsors gain direct access to subject matter experts and decision-makers who understand the unique demands of cancer and imaging-based technologies.

surgeons performing a surgical procedure

Deep Therapeutic & Industry Insight

Our teams are steeped in oncology and radiology indications spanning breast, prostate, liver, and lung cancers, as well as interventional radiology and diagnostic imaging. Their backgrounds, ranging from device manufacturers to clinical practice, equip them to anticipate regulatory and operational pitfalls before they arise.

We were among the first CROs to support a De Novo submission for AI-driven imaging diagnostics, demonstrating our ability to adapt to evolving regulatory frameworks and technology convergence.

MRI scanning procedure control room

Consistent, Dedicated & Flexible Teams

Sponsors value Avania’s stability, responsiveness, and collaborative spirit. We assign specialized clinical and medical SMEs aligned with each study’s leading indication, whether hepatology, urology, or oncology, ensuring the right expertise at every stage.

Our teams operate as a seamless extension of your organization: communicating clearly, adapting quickly, and maintaining the professionalism that drives lasting partnerships.

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Integrated Solutions for Oncology & Radiology Innovation

Avania delivers integrated regulatory, clinical, and operational support across the full development lifecycle. From strategic planning through study execution and market access, our multidisciplinary structure keeps every element aligned toward one goal: successful commercialization.

Strategic Consulting & Regulatory Pathways

Avania’s regulatory specialists are experts in oncology and radiology pathways at the PMA level, with extensive experience in CDRH-led reviews and inter-center coordination with CBER and CDER.

Our teams manage complex submission schedules, responses, and regulatory interactions to ensure momentum and minimize delays.

We also maintain strong working relationships with the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) and the Office of Radiological Health (OHT8), supporting sponsors in the development of imaging, radiation, and AI-enabled technologies.

Clinical Development & Execution

Executing oncology and radiology trials demands precision and adaptability. Avania’s project management and monitoring teams deliver both, coordinating site management, imaging logistics, and safety oversight to maintain data integrity and compliance across every location.

  • Global experience with complex, multi-site oncology and radiology programs
  • Expertise in imaging workflows and centralized data systems
  • Seamless integration of core lab, safety, and logistics operations
  • Rigorous focus on quality, patient safety, and regulatory standards

Our Track Record

Demonstrated Success in Oncology & Radiology

Avania has supported a broad portfolio of oncology and radiology technologies through feasibility, pivotal, and post-market studies, delivering a consistently high probability of approval and market success.

The patient lies inside an MRI

Representative Device Experience

  • Stereotactic Body Radiation Therapy (SBRT) systems
  • Selective Internal Radiation Therapy (SIRT) technologies
  • Hydrogel spacers and infusion pumps
  • Localization and navigation devices
  • Transcatheter Arterial Embolization (TAE) / Chemoembolization (cTACE) systems for tumor treatment
  • AI-enabled medical imaging and multi-reader, multi-case (MRMC) diagnostic studies
In the MRI or CT control room

Regulatory Engagement

  • Proven success managing CDRH-led reviews with cross-center (CBER/CDER) coordination
  • Frequent collaboration with OHT8 and DIDSR on imaging and radiation submissions
  • Expertise in AI, ML and SaMD
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Client

Successes

Our oncology and radiology portfolio spans a wide range of interventional, diagnostic, and therapeutic technologies evaluated across 20+ countries. With more than 100 MedTech projects, Avania offers unmatched experience driving oncology and radiology innovations from concept to commercialization.

“Working with Avania has been a consistently professional and rewarding experience. As a committee chair, I’ve seen firsthand how thoroughly prepared their team is — they come to the table with a deep understanding of the regulations and a clear commitment to doing things the right way. They take their role seriously, balancing scientific rigor with practical execution. The team is well-trained, thoughtful, and genuinely invested in the success of each study. It’s clear they care — not just about the data, but about the people and the outcomes. That level of dedication makes all the difference.”

Dr. Karin Andersson, MD
Gastroenterologist and Transplant Hepatologist at Massachusetts General Hospital

Case Study

Securing First-in-Class FDA Approval Through Advanced Statistical Strategy

Device:

Hydrogel embolic system for vascular occlusion of hyper vascular tumors

Solution:

Avania supported statistics and FDA consulting, navigating through complex analysis and FDA communications

Problem:

Complex statistically analysis needed, with multiple sensitivity analyses

Outcome:

First of its kind, FDA-approved product supported by the statistical analysis of the prospective, randomized control trial

Case Study

Achieving PMA Approval by Reframing Dense Breast Screening Evidence

Device:

Radiological software used as adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue

Solution:

Avania reviewed the data collected to date, performed an in depth assessment of study conduct and protocol adherence, and worked on the conduct of an additional multi-reader, multi-case study in support of gathering additional primary and secondary outcome data; Avania supported the PMA submission and program planning surrounding BIMO prep

Problem:

Sponsor came to Avania with trial data that displayed a failed primary endpoint

Outcome:

The program was submitted to FDA in totality as part of a PMA; the sponsor received FDA PMA approval as clinical evidence demonstrated that the software enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone

Case Study

Advancing Pancreatic Cancer Innovation Through Strategic Global Trial Design

Device:

Neoadjuvant Therapy for PDAC (Pancreatic Ductal Adenocarcinoma)

Solution:

Avania partnered with the client on a strategy to conduct the initial study in Australia, leveraging KOLs in the space as well as tax incentives that make clinical research in Australia attractive

Problem:

Client needed to conduct a first-in-human, Phase I, study for their device being developed for the treatment of pancreatic cancer; the program is being advanced using a well established, highly potent approved drug for treating pancreatic cancer (paclitaxel), as well as a commonly used laparoscopic procedure for implantation of the device delivering the drug

Outcome:

The client collected their Phase I data in Australia to schedule, demonstrating local response alongside a strong safety profile; the program has advanced to global Phase II research

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Oncology & Radiology Experts Today

Oncology and radiology device innovation demands collaboration across disciplines, geographies, and regulatory frameworks. Avania brings the specialized knowledge, operational strength, and strategic foresight to guide your technology from prototype to patient impact.

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