Breakthrough Medical Imaging

A partner from beginning to endpoint

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Download Our Brief: Behind the Breakthrough

Every trial will have surprises. The key is how your team pivots to resolve issues and seize opportunity – all the more intense when  worldwide regulatory agencies are providing daily guidance. See what happens in a Breakthrough Therapy trial, and when the stakes are sky high.

Thank you. We’ll be in touch soon.

Download: Behind the Breakthrough

Lives are in your hands. 
Put your trial in ours.

You can trust our medical imaging expertise – from beginning to endpoint – because of our scientific expertise, flexible operational processes, innovative technology and centralized image review methodologies.

The proof lies in the groundbreaking approvals we’ve supported, including those with the worldwide regulatory agencies new Breakthrough Therapy designation.

Breakthrough vs. Regular Approval Pathways

Whether you pursue the highly prized Breakthrough Therapy designation or other pathways, medical imaging serves as a surrogate endpoint, revealing the effect of a drug much earlier than traditional endpoints.

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blue-dl-icon.png 

Download Our Brief: Behind the Breakthrough

Every trial will have surprises. The key is how your team pivots to resolve issues and seize opportunity – all the more intense when  worldwide regulatory agencies are providing daily guidance. See what happens in a Breakthrough Therapy trial, and when the stakes are sky high.

Thank you. We’ll be in touch soon.

Download: Behind the Breakthrough

When approval depends on medical imaging as your surrogate endpoint, you need confidence that your partner brings:  

Scientific expertise to guide

study design and charter development, through regulatory support and submission

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Proven processes and systems

operaltionalize a study at every step, from site on-boarding to daily flow of images and queries.

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Rigorous reviews for data integrity

to flag image problems early and ensure precise independent image reading and analysis

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If you are considering pursuing a breakthrough designation, what therapeutic area does your study target?

*Please select one.
SEE THE RESULTS