Clinical trial strategy & operations

Clinical trial strategy, from protocol to submission

Study design, vendor oversight, imaging, biomarkers, data, and regulatory.

Our team See where we fit

Bracken plans and oversees clinical trials for sponsors on a fractional or embedded basis, at any stage from preclinical to market.

15 Therapeutic areas supported
400+ Peer-reviewed publications across the group
Preclinical to market Support at every stage of the trial process
Seed to F500 Client scale, from startups to Fortune 500

What We Do

Bracken's clinical trial consulting works on the sponsor side of the table. We design the study, choose and manage the vendors who run it, and protect the quality of the data that decides whether it succeeds. Engagements range from a single advisor on one protocol to a team acting as your clinical operations function.

  1. 1

    Plan

    Decisions made here set the cost and risk of the whole trial.

    • Study design and protocol development
    • Endpoint selection and evaluation
    • Patient eligibility and recruitment considerations
    • Biomarker selection and companion diagnostics
  2. 2

    Set up

    The right partners and a clear regulatory path before first patient in.

  3. 3

    Conduct

    Oversight that catches problems while they can still be fixed.

    • CRO and vendor management
    • Imaging quality and site training
    • Data management
    • Biomarker analysis
  4. 4

    Analyze & report

    Results that answer the question the trial was built to ask.

    • Endpoint and imaging analysis
    • Biomarker development and validation
    • Regulatory submission
    • Commercialization planning

Bracken is a concierge-style life sciences consultancy, and its consultants are regularly asked to serve as fractional CMOs, CSOs, COOs, or Heads of Regulatory. Sponsors that need an ongoing clinical operations function rather than an advisor work through our Functional Service Provider model. Trials with radiolabeled agents draw on our Radiopharmaceutical team, and imaging-heavy programs on Medical Imaging Strategy & Operations.

Therapeutic Areas

Bracken supports clinical trials in fifteen therapeutic areas. Highlighted areas have dedicated practice pages.

  • Cardiovascular
  • Dermatology
  • Endocrinology
  • Gastrointestinal
  • Inflammatory diseases
  • Liver diseases
  • Neurology
  • Oncology
  • Ophthalmology
  • Osteoarthritis
  • Osteoporosis
  • Pediatric conditions
  • Rare diseases
  • Rheumatology
  • Women's health

See the Evidence

Our Consultants

Former pharma and biotech executives, physicians, imaging scientists, and regulatory specialists. Full profiles and credentials.

Meet the Team

Client Case Studies

Published engagements, including DXA scan quality in a multi-site Phase 2 GLP-1 trial and imaging endpoint support.

Case Study Library

Our Publications

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

Browse Publications
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Questions

What does clinical trial strategy consulting cover at Bracken?
The full course of a trial: planning, set-up, conduct, analysis, and reporting. That includes study design and protocol development, endpoint selection, patient eligibility and recruitment, CRO and vendor oversight, imaging and biomarker strategy, statistical analysis plans, data management, and regulatory submission. Engagements run from a single advisor to a fully embedded team.
Does Bracken replace our CRO?
No. Bracken works on the sponsor side. We help evaluate and select CROs and specialist service providers, then oversee their delivery so the trial stays on protocol, on schedule, and on budget. Sponsors without an internal clinical operations function can bring Bracken in to act as one. See our Functional Service Provider model.
Which therapeutic areas does Bracken support?
Cardiovascular, dermatology, endocrinology, gastrointestinal, inflammatory diseases, liver diseases, neurology, oncology, ophthalmology, osteoarthritis, osteoporosis, pediatric conditions, rare diseases, rheumatology, and women's health.
Can Bracken help with imaging endpoints and biomarkers?
Yes. Medical imaging is one of Bracken's core specialties, from preclinical work through endpoint selection, reading, and site quality. Bracken also supports biomarker selection, analysis, development, and validation, and companion diagnostics strategy. See Medical Imaging Strategy & Operations.
When should we bring Bracken into a clinical trial?
Earliest is best, while the protocol, endpoints, and vendor choices are still open, because those decisions set the cost and risk of everything that follows. Bracken also joins trials already underway, typically to resolve a data quality, vendor, or endpoint problem before it reaches the analysis.

Talk to our team

Tell us where your trial is and what it needs next.

Start a conversation Or call +1 215 648 1208