Musculoskeletal strategy & operations

Musculoskeletal consulting from discovery to launch

Osteoarthritis, osteoporosis, rheumatoid arthritis, and congenital muscle disorders.

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Bracken's MSK consultants bring clinical, imaging, regulatory, and commercial expertise on a retainer or ad hoc basis, scaled to what your program needs next.

200+ Peer-reviewed publications on musculoskeletal diseases
Full lifecycle Discovery through clinical execution, regulatory, and launch
3 textbooks On osteoporosis, arthritis, and imaging trials, written by our consultants
Seed to F500 Client scale, from startups to Fortune 500

What We Do

Bracken provides musculoskeletal (MSK) consulting to drug, device, and diagnostics developers and the investors behind them. We start by assessing where your program stands, then scale support to match: one advisor on an imaging endpoint, a fractional leader, or a full team running MSK trials alongside yours.

  • Osteoarthritis, osteoporosis, and rheumatoid arthritis drug development
  • Therapeutics for congenital muscle disorders
  • Small molecule, peptide, protein, and cell therapy programs
  • Drug delivery and medical device development
  • Clinical trial design and personalized medicine
  • Imaging and biochemical marker endpoints, from DXA to MRI cartilage
  • Scientific and operational management of MSK clinical trials, including medical imaging
  • Regulatory strategy and agency interactions
  • Diagnostic techniques, commercialization, and marketing strategy
  • M&A, licensing, investment, and launch of MSK-focused businesses

Bracken is a concierge-style life sciences consultancy whose mission here is simple: support the businesses that improve musculoskeletal health. Programs that need an ongoing operating function rather than an advisor run through our Functional Service Provider model. Bone density work is covered in detail below; broader imaging endpoint work connects to Medical Imaging Strategy & Operations, and submissions sit under Regulatory Affairs.

DXA and Bone Density in Clinical Trials

Dual-energy X-ray absorptiometry (DXA) is the standard measure of bone mineral density in osteoporosis trials, and one of the easiest endpoints to compromise across a multi-site study. Bracken's team brings more than 35 years in bone densitometry and clinical trial imaging, including directing clinical services at a DXA company within Lunar Corp. and leading a pharmaceutical sponsor's European physical measurements team.

  • DXA and QCT cross-calibration. Phantom-based and in-vivo calibration so scanners from different manufacturers and sites produce comparable results.
  • Precision studies and site quality control. Establishing measurement precision at each site and keeping scanner QC in check for the life of the trial.
  • Vertebral morphometry and fracture endpoints. Endpoint design for vertebral fracture assessment, including automated vertebral characterization from radiographs.
  • Whole-body composition. DXA lean mass and fat mass endpoints, with cross-calibration validated against human subjects and spine and whole-body phantoms.
  • Imaging core lab selection and oversight. Design, selection, oversight, and quality assurance of the central lab that reads your DXA, QCT, X-ray, and MRI data.
  • Osteoarthritis joint imaging. Radiographic joint space narrowing, MRI cartilage assessment, and OARSI-aligned imaging protocols for DMOAD trials.

See the Evidence

Our Consultants

Osteoarthritis drug discovery leaders, osteoporosis launch veterans, DXA and quantitative MRI specialists, and biomarker statisticians. Full profiles and credentials.

Meet the Team

Our Publications

More than 200 peer-reviewed papers on musculoskeletal diseases from the consultants who would work on your program.

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Client Case Studies

Published MSK engagements, including anti-NGF imaging endpoint design and monitoring, and DXA in clinical trials.

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Questions

What does musculoskeletal consulting cover at Bracken?
Full lifecycle support for musculoskeletal (MSK) programs, from discovery through clinical execution, regulatory strategy, and commercialization. That includes clinical trial design, imaging and biochemical marker endpoints, diagnostic techniques, and marketing strategy, across small molecules, peptides, proteins, cell therapies, drug delivery, and medical devices.
Which musculoskeletal indications does Bracken work in?
Osteoarthritis, osteoporosis, and rheumatoid arthritis drug development, plus therapeutics for congenital muscle disorders. Bracken's MSK consultants have authored more than 200 peer-reviewed publications on musculoskeletal diseases; see Consultant Publications.
Can Bracken design imaging endpoints for osteoarthritis and osteoporosis trials?
Yes. Imaging and biochemical marker endpoints are a core part of Bracken's MSK work, along with the scientific and operational management of the trials that use them. For osteoarthritis, that covers radiographic joint space narrowing, MRI cartilage assessment, and OARSI-aligned imaging protocols. Published examples include designing and monitoring imaging endpoints for anti-NGF analgesic programs and advising clients on dual-energy X-ray absorptiometry (DXA) in clinical trials.
Does Bracken have DXA expertise for osteoporosis and body composition trials?
Yes. Bracken's team has more than 35 years of experience with DXA and QCT in clinical trials, covering cross-calibration, precision studies, site quality control, vertebral morphometry, fracture endpoint design, and whole-body composition. Bracken consultants hold patents on DXA calibration and body composition phantoms and wrote the Springer textbook Clinical Trials in Osteoporosis. See DXA and bone density above.
Does Bracken support regulatory strategy and FDA interactions for MSK products?
Yes. Bracken provides regulatory affairs strategy for musculoskeletal drugs, biologics, and devices, including preparation for and support during agency interactions. See Regulatory Affairs for the wider capability.
How do engagements with Bracken's MSK team work?
On a retainer or ad hoc basis, scaled to the program. Bracken first assesses the project to understand where it stands, then recommends the next strategic steps. Support ranges from a single advisor to fractional leadership roles or an embedded team through the Functional Service Provider model.
Does Bracken advise investors and acquirers on MSK assets?
Yes. Bracken supports mergers and acquisitions, licensing, investment decisions, and the launch of MSK-focused businesses, bringing scientific, clinical, and regulatory diligence to the evaluation of musculoskeletal assets. See Mergers & Acquisitions Advisory.

Talk to our team

Let's discuss where your musculoskeletal program is and what it needs next.

Start a conversation Or call +1 215 648 1208