Medical Imaging Strategy & Operations

Medical imaging in trials takes core lab experience on both sides of the table.

Bracken's imaging consultants design endpoints, select and manage core labs and CROs, and step in when an imaging endpoint is already going wrong, on a fractional or embedded basis.

Talk to our team See the evidence Imaging Charter Checklist

Called in mid-trial to rescue a Phase 3 oncology study when its imaging endpoints went wrong.

15 Consultants publishing peer-reviewed imaging research
20+ Products supported through successful imaging data submissions
2 Published case studies on medical imaging engagements

What We Do

Medical imaging drives eligibility, safety, and efficacy endpoints in clinical trials. Bracken's imaging consultants bring experience from both imaging core labs and embedded pharma teams, across oncology, musculoskeletal, DXA, and neurology imaging. Our CEO, Colin G. Miller, co-authored Medical Imaging in Clinical Trials, the field's textbook, published by Springer.

  • Imaging biomarker selection, validation, and endpoint strategy
  • Imaging CRO and core lab selection, oversight, and vendor management
  • Reader paradigm design, including RECIST 1.1, Lugano, and RANO criteria
  • Reader calibration, adjudication rates, and inter/intra-reader variability
  • Imaging charter development and protocol-language optimization
  • Mid-trial imaging rescue studies
  • DXA, oncology, musculoskeletal, and neurology imaging expertise
  • Regulatory strategy for imaging companion diagnostics and FDA interactions

Bracken's imaging practice sits alongside our radiopharmaceutical strategy work, and several consultants work across diagnostic imaging, PET/SPECT development, and theranostics on the same programs. See Radiopharmaceutical Strategy & Operations.

See the Evidence

Our Consultants

Fifteen consultants publish peer-reviewed imaging research, including radiologists, MRI technique specialists, and imaging-biomarker scientists.

Meet the Team

Our Publications

Peer-reviewed imaging papers, filterable by topic, from the consultants who would work on your program.

Browse Publications

Client Case Studies

Published engagements including a mid-trial Phase 3 oncology imaging rescue and DXA scan-quality remediation.

Case Study Library
Imaging Charter Checklist Confirm your imaging charter captures the details a mid-trial rescue always finds missing.
Download the Checklist

Questions

What does Bracken's medical imaging consulting cover?
Imaging endpoint selection and protocol language, core lab and CRO selection and oversight, reader paradigm design such as RECIST 1.1, Lugano, and RANO, imaging charter development, and mid-trial imaging rescue studies, across oncology, musculoskeletal, DXA, and neurology imaging.
Can Bracken step in if an imaging endpoint is already going wrong mid-trial?
Yes. Bracken's CEO, Colin G. Miller, is frequently sought after for imaging rescue studies, helping turn around trials where imaging endpoints were not handled correctly, including a published case study on stepping into a Phase 3 oncology trial mid-study.
Which reader paradigms and imaging modalities does the team work with?
RECIST 1.1, Lugano, RANO, and other modality-specific criteria, across oncology, musculoskeletal disease including osteoarthritis and osteoporosis, DXA, and neurology imaging. The team includes consultants with backgrounds in MRI technique development and quantitative biomedical imaging.
How does medical imaging connect with Bracken's radiopharmaceutical work?
Closely. PET and SPECT imaging biomarkers underpin much of radiopharmaceutical development, and several Bracken consultants work across diagnostic imaging, radiopharmaceuticals, and theranostics on the same programs. See Radiopharmaceutical Strategy & Operations for the wider capability.

Talk to our team

Let's discuss where your imaging endpoints stand today, and what a stronger protocol looks like.

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