From discovery to market

We provide full-service Imaging Diagnostics Clinical Development, from pre-clinical to IND and NDA submission and Medical Affairs.

We have developed current market leaders

We have led 9 new drug approvals globally: MRI, CT, and radiopharmaceuticals.

Literature-based approvals

Utilizing only existing literature reviews, we have gained 5 new indications for imaging drugs without performing additional clinical trials.

Over 40 years of experience

Between our two RadMD principals, there are over 40 years of contrast agent development experience.

Clinical Development Experience:

Supervised clinical development (phase I to phase IV) for:

9

MRI contrast agent

3

CT contrast agent

1

1 ultrasound agent

5

PET & SPECT agents

Regulatory Experience:

  • Submitted NDAs for contrast agents and radiopharmaceuticals in multiple countries
  • Clinical lead for regulatory discussions globally
  • Contributed to development guidelines for FDA and EMA

Medical Affairs Experience:

  • Medical Affairs strategies
  • Advisory boards
  • KOL interactions
  • Post approval material and commercial material in the USA and Europe
  • Training of scientific affairs personnel and sales force
  • Interacted with regulatory, legal, and clinical teams for approval of clinical material

Imaging management solutions

Our full-service imaging management solutions provide a comprehensive set of services to support pharmaceutical, medical device, and AI companies with their clinical trials.

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Our reader group

We are the global leader in providing consultants to perform imaging BICR (blinded independent central reviews)

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Oncology

A radiologist-led imaging provider focusing on blinded central and site reads with a specialty in oncology trials

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AI validation

RadMD is the global leader providing expert readers, truthers, and core lab operations to perform blinded imaging and clinical reviews to meet the rigorous needs of AI imaging trials

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Let’s work together on your clinical trial

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