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