Neuroscience & CNS strategy & operations

CNS programs succeed or stall on what they can measure

Biomarkers, imaging, outcome measures, and study design for neuropsychiatry, neurodegeneration, pain, and neuromuscular programs.

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Bracken puts neuroscientists, imaging scientists, biostatisticians, and regulatory specialists on your program, fractional or embedded, from preclinical to market.

15 Neuroscience capabilities under one consultancy
9 CNS therapeutic areas, spanning psychiatry, neurology, and pain
19 Named CNS indications, from depression to ALS

What We Do

Bracken provides neuroscience consulting for companies developing therapies for the central nervous system. We plug into programs wherever the needs lie: one advisor on an outcome measure, a fractional CMO, a scientific advisory board, or a group operating as your neuroscience team outright.

  • Study design, clinical development plans, and data safety monitoring boards
  • Biomarkers, diagnostics, and precision medicine
  • Neuroimaging endpoints with MRI, fMRI, and PET
  • Clinical outcome assessments, patient-reported and clinician-reported
  • Biostatistics, disease progression modeling, large datasets, and RWD/RWE
  • Pharmacology, pharmacogenetics, and preclinical development
  • Regulatory strategy, FDA meetings, INDs, NDAs, and BLAs
  • Psychedelic and other novel-modality CNS programs
  • Medical affairs and scientific advisory board management
  • Patient recruitment and engagement, operations, and marketing

Bracken is a concierge-style life sciences consultancy, and its consultants regularly serve as fractional CMOs, CSOs, or Heads of Regulatory, without the overhead of a full-time hire. Programs that need an ongoing operating function run through our Functional Service Provider model. Imaging endpoints connect to Medical Imaging Strategy & Operations, and submissions sit under Regulatory Affairs.

Therapeutic Areas

  • Neuropsychiatry and mental health

    Major depressive disorder, bipolar disorder, PTSD, schizophrenia, and eating disorders

  • Alzheimer's disease and related dementias

    Frontotemporal dementia and Lewy body dementia

  • Neurodegeneration

    Biomarker strategy and disease progression modeling for disease-modifying therapies

  • Parkinson's disease and movement disorders

    Imaging biomarkers and motor outcome measures

  • Multiple sclerosis

    Quantitative MRI endpoints and long-term outcome measures

  • Neuromuscular disorders

    Muscular dystrophy, myotonic dystrophy, and ALS

  • Chronic pain

    Nociplastic and neuropathic pain, including fibromyalgia, migraine, and CRPS

  • Stroke

    MRI techniques, imaging endpoints, and recovery measures

  • Traumatic brain injury

    MRI techniques and imaging endpoints for injury and recovery

See the Evidence

Our Consultants

Neuroscientists, neuroimaging scientists, biostatisticians, and physician drug developers. Full profiles and credentials.

Meet the Team

Our Publications

Peer-reviewed publications, book chapters, and patents from the consultants who would work on your program.

Browse Publications

Client Case Studies

Published engagements across clinical development, imaging endpoints, patient engagement, and regulatory readiness.

Case Study Library
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Questions

What does neuroscience consulting cover at Bracken?
Drug development strategy and operations for central nervous system programs, from preclinical work through regulatory submission and launch. That includes study design and clinical development plans, biomarker strategy, MRI, fMRI, and PET imaging endpoints, clinical outcome assessments, biostatistics, pharmacology and pharmacogenetics, regulatory strategy, and medical affairs. Engagements run from a single advisor to an embedded team.
Which CNS indications does Bracken work in?
Neuropsychiatry and mental health, including major depressive disorder, bipolar disorder, PTSD, schizophrenia, and eating disorders; Alzheimer's disease and related dementias; neurodegeneration; Parkinson's disease and movement disorders; multiple sclerosis; neuromuscular disorders such as muscular dystrophy, myotonic dystrophy, and ALS; chronic pain, including fibromyalgia, migraine, and CRPS; stroke; and traumatic brain injury.
How does Bracken approach endpoints in CNS clinical trials?
CNS trials often depend on subjective measures and show high placebo response, so endpoint choice decides whether a trial can read out. Bracken pairs clinical outcome assessments, both patient-reported and clinician-reported, with objective measures where they help, including imaging biomarkers and disease progression models, and builds the statistical analysis plan around them from the start. See Medical Imaging Strategy & Operations for imaging endpoint work.
Who are Bracken's neuroscience consultants?
The group includes Jeffrey Cottrell, PhD, a neuroscientist and former Head of Neurodevelopment and Psychiatry at the Novartis Institutes for BioMedical Research; William Reinus, MD, MBA, a radiologist who has published on MRI in traumatic brain injury and stroke; Bernard Dardzinski, PhD, a quantitative MRI and PET imaging scientist; David Raunig, PhD, who has led disease progression modeling in neurodegeneration; David Krause, MD, former Chief Medical Officer of the pharmacogenetics company Genomind; and Jim Gilligan, PhD, whose drug development work includes psychedelic-assisted psychotherapy. Full profiles are on Our Team.
Does Bracken support psychedelic drug development?
Yes. Psychedelic programs raise problems most CNS programs do not: controlled substance regulation, the difficulty of blinding a trial when the drug's effects are obvious to participants, and a treatment model that combines a drug with psychotherapy. Bracken supports trial design, comparator and dose-response strategies, and regulatory planning for these programs.
Can Bracken serve as our fractional CMO or scientific advisory board?
Yes. Bracken consultants serve in clinical, regulatory, scientific, and strategic advisory roles, including as fractional CMOs, CSOs, and Heads of Regulatory, without the cost of a full-time hire. Bracken can also set up and manage a scientific advisory board drawn from its in-house consultants and wider associate network. See the Functional Service Provider model.
Clinical Trial Strategy

Planning a CNS trial?

Bracken designs and plans clinical trials built to succeed scientifically and commercially, from protocol to data interpretation.

Our Strategic Approach

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

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