Oncology Medical Imaging Expertise

World-class scientific expertise and unmatched regulatory insight combine to expedite oncology drug development

Medical imaging plays a key role in evaluating the efficacy and safety of new oncology treatments. As a sponsor, you require a solution that keeps pace with advances in oncology imaging and stays ahead of demanding timelines and budgets. Clario combines world-class scientific expertise with outstanding project management and unmatched regulatory insight to expedite oncology drug development.

Clario is specifically structured to reduce risk to key areas of clinical development, offering the flexibility and scalability necessary to meet your oncology project needs. Our nearly five decades of experience include advanced capabilities in small early-phase molecular imaging studies to large, more complex, late-phase registrational trials. Clario leads the industry with over 1,200 oncology trials, of which 100+ were FDA-approved.

Expert independent review

Clario’s independent reviewers have experience with the latest advancements in tumor response criteria, imaging modalities and oncology biomarkers, ensuring an innovative solution and world-class resources in support of oncology clinical trials with imaging endpoints. Clario’s team of board-certified, sub-specialty trained radiologists, nuclear physicians, and medical oncologists can analyze all images from baseline through follow-up with fast turnaround times and can provide a blinded, comprehensive oncology response review.

• Sophisticated algorithms for semi-automatic, bi-dimensional, and volumetric tumor measurements
• Quantitative and qualitative assessments
• Custom-designed lesion tracking for longitudinal studies
• Real-time derivation for accelerated calculations and reduced error
• Automatic transfer of image analysis data into eCRFs
• Correlation to tumor treatment intervention

On-staff oncologists and radiologists complemented by a worldwide network of key opinion leaders, led by our Chief Medical Officer, Michael O’Neal, MD

Medical and scientific experts with advanced knowledge of imaging modalities including CT, MRI, PET, and bone scan

Oncology project management teams with phase, indication and assessment criteria experience focused on your timelines, metrics and budgets

Global offices in North America, Asia and Europe

Unparalleled regulatory experience with 100+ FDA oncology approvals

Study and protocol design consulting

Site imaging capability oversight and training to help ensure standardization across sites

21 CFR Part 11 and GDPR compliant imaging platform

Experience in operationalizing new and evolving response criteria in real time

Real-time read monitoring for all projects

Experienced medical writing professionals driving Imaging Review Charter development by leveraging internal and external experts

Immuno-oncology

Recent advances in personalized medicine and immunotherapies have driven an increase in immuno-oncologic drug development. Clario offers detailed understanding of established assessment criteria as well as extensive expertise in the application of several different approaches including iRECIST and irRECIST.

Cardio-oncology

The association of many oncology drugs have cardiotoxic side effects, studies of compounds in development oftentimes include cardiac safety endpoints, such as cardiac imaging (Echo and cardiac MR) as well as electrophysiology (ECG) and hemodynamic (BP), to define the potential cardiac safety signal and benefit-risk considerations. Clario has extensive expertise in planning and supporting successful cardiac safety studies to assess the risk of oncology treatments early in clinical development.

Regulatory leadership

Clario senior management continues to take an active leadership role in the establishment of processes, methods and counsel that shape new regulatory guidance for imaging endpoints. Our experts have a detailed understanding of Imaging Review Charter requirements and protocol development, adhering to recommendations and feedback from the FDA, EMA, and other international regulatory agencies. We have substantial skill in supporting regulatory submissions and inspections.

Molecular imaging expertise

Advances in molecular imaging enable the ability to measure functional changes in tumor microenvironments. Clario supports a full range of molecular imaging modalities used to identify, stage, and monitor various cancers.

• ¹⁸F-fluorodeoxyglucose (FDG)
• 3’-deoxy-3’-¹⁸F-fluorothymidine (FLT)
• ¹⁸F-fluoromisonidazole (FMISO)
• ¹⁸F-NaF
• ¹¹¹In-octreotide
• ¹²³I-metaiodobenzylguanidine (mIBG)
• 99m -Tc- MDP
• 68Ga PSMA PET and 68Ga-DOTATATE

With decades of imaging experience, over 1,700+ oncology trials, and 100+ FDA approved oncology trials, Clario leads the industry.