Bringing a new oncology treatment to regulatory approval requires an imaging partner with world class systems and experience. 

The risks and costs of doing it wrong are far too great to compromise your development program. Synarc’s oncology team includes the top scientists and clinicians at the forefront of oncology research.

The Synarc oncology team can partner with you to determine the biochemical markers, imaging markers, image-acquisition techniques, and data-reporting methods most applicable to your oncology clinical trial.

Worldwide regulatory experience

Our team’s extensive global regulatory experience provides your organization with centralized independent evaluations of pivotal studies and phase III surrogate endpoints. We will also help to minimize your regulatory risk by develop your imaging charters and present them before regulatory bodies on your behalf.

Achieving successes with demanding requirements

RECIST/WHO-based studies

Centralized imaging analysis from Synarc enhances the accuracy, reproducibility, and consistency of your response evaluation – in full compliance with rigorous scientific and regulatory guidelines.

IHP criteria-based studies

Synarc’s in-house, highly skilled imaging scientists and physicists ensure accurate, consistent and reproducible image readings. Synarc focuses on careful training and monitoring of your participating sites to ensure reliable image acquisition.

DCE-MRI–based studies

DCE-MRI is among the most powerful techniques for evaluating antiangiogenic drugs, and Synarc has successfully implemented DCE-MRI clinical trials at over 15 sites in the US, Canada, Europe, Australia, New Zealand, and Japan.  Despite the complexity and technical demands of the imaging and analysis, Synarc has been able to achieve a remarkably low data loss rate (< 10 %) by emphasizing robust protocol design, specialized on-site training, QC with 24 - 48-hour turn-around-time, and on-going site support from experienced Synarc physicists and operations specialists. 

Additional High-level Support

• Study design and imaging protocols 
• Multi-national logistics management 
• Global site selection and training 
• Quality assurance of imaging acquisition and specimen collection 
• Centralized image analysis by expert in-house radiologists:
• Computer-aided image analysis
• RECIST, WHO, IHP criteria 
• 3D volume estimation
• Tumor pharmacokinetic automated modeling and analysis using DCE-MRI
• Tumor metabolism using PET imaging
• Burden of bone metastases using bone scan index (BSI), Soloway index, flare phenomenon measurement
• Time-sequence blinding
• Electronic CRFs
• 21 CFR Part (11) compliant systems with electronic audit trails
• Comprehensive data management 
• Biochemical marker analysis using fully validated manual and automated assay technology   
• Regulatory consulting and liaison
• Imaging charters