Raising the bar

We embrace early phase trials

With a flexible, cost-conscious approach to an imaging strategy that provides insight on the safety and efficacy of your compound

Reducing site/central discordance

Site training and reader oversight reduce discordance and harmonize read results, meeting an important regulatory objective

Preeminent reader group

The industry relies on RadMD readers as the most qualified, trained, and managed group for clinical trials

Site reader and trial team criteria training

Our comprehensive, customized online training courses are available throughout the trial for all training requirements and are proven to improve image acquisition, protocol adherence, and site reads

“We will never lose focus on what has always been the most important task: the image reads. It is the reads that determine if a drug works. Everything else is secondary and supportive of the highest quality reads possible.”

Rick Patt MD, Director of Medical and Scientific Affairs

Imaging assessments in early phase oncology trials

Many clinical development teams find themselves questioning:

Imaging endpoints are often used to support go/no-go decision making in early phase trials. This is also a critical time to determine the development strategy for later study phases.

  • What imaging biomarkers should we target?
  • What endpoints and criteria best suit the compound?
  • Are central reads necessary for all subjects?
  • Should we just collect and hold images? If so, what decision tree do we use to pull the trigger on central reads?
  • What supporting clinical data should be collected?
  • What types of radiology support do we need?

Advanced imaging capabilities

  • Tumor volumetrics
  • Tumor segmentation (necrosis vs. viable)
  • Radiomics (customized parameters possible)
  • Tumor perfusion kinetics

The RadMD difference

Imaging risks that will affect your trial and the RadMD solution

Site based reads are risky, inaccurate, and inconsistent*

  • Site physicians and radiologists not trained on RECIST
  • Clinical Management reads are more qualitative; not surrogates for RECIST
  • Early Phase imaging for decision-making benefits from a more novel, consultative approach with review meetings regularly, with development team to review imaging results
  • Limited sponsor budgets for early phase trials and lack of flexibility by traditional core labs deter us from central imaging solutions

*Oncologic Errors in Diagnostic Radiology: A 10-Year Analysis Based on Medical Malpractice Claims, Journal of the American College of Radiology, Volume – n Number – n Month 2021

The RadMD solution

Early phase imaging for oncology trials

  • Controlled image reviews provide an understanding of:
    • Drug MOA
    • Off-target effects
    • Efficacy and safety
  • Development of imaging protocol in consultation with RadMD experts
  • Standardization of site reads and site/central discordance management
  • Site reader training and/or confirmatory central reads
  • Rapid start up
  • Budget friendly with full regulatory compliance

Breadth of experience

  • HCC
  • NSCLC
  • Breast cancer
  • Colorectal cancer
  • Gastric cancer
  • Pancreatic cancer
  • Bladder cancer
  • Renal cell carcinoma
  • Non-Hodgkin's Lymphoma
  • Melanoma
  • Ovarian cancer
  • Follicular lymphoma
  • T-cell lymphoma
  • Endometrial cancer
  • Giant cell tumor of the bone
  • Glioblastoma
  • Advanced Head and Neck cancer
  • SCCHN
  • SCLCA
  • Neuroendocrine tumor
  • Advanced carcinoid tumor
  • Nasopharyngeal cancer
  • SCC oral cavity
  • Sarcoma
  • Thyroid cancer

Utilizing various criteria:

RECIST 1.0,1.1, Cheson, Lugano, RANO/McDonald or specially modified criteria guided by RadMD Expertise

Case study
Clinical trials expertise

Areas of expertise

With our deep reader pool and expert approach, RadMD is here to support you wherever your research leads

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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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CNS Clinical trials

CNS

Our team of neuroradiologists and CNS experts will be your source of confidence for establishing imaging endpoints and biomarkers when researching cures for CNS disorders

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Diagnostic imaging agents

Unparalleled expertise and a proven track record in bringing drugs to approval

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Let’s work together on your clinical trial

Contact us