Services
Clinical Utility Consulting, LLC offers a range of services critical to the mission of early- to mid-stage biotechnology, digital health and online health information companies.
Strategy Consulting
Our strategy consulting services are focused primarily on two areas:
- Clinical Validity and Clinical Utility of drugs, devices, and diagnostics
- Navigating the turbulent and disruptive atmosphere in the areas of personalized medicine/healthcare and digital health online
Clinical Research
Our clinical research consulting services are focused in the following areas:
- Clinical Research Study Design - Prospective and Retrospective
- Navigating IRBs and Human Subjects Applications
- Identification of Suitable Sources of Research Patients and/or Sample Sets
Medical Affairs
Our medical affairs consulting services are focused in the following areas:
- Identification and recruitment of key opinion leaders for clinical advisory boards
- Medical oversight and/or authorship of key drug- or diagnostic-related documents
- Relationship building with patient advocacy and/or professional medical societies
- Providing interim medical affairs support for companies while they recruit a permanent medical affairs professional
Competitive Intelligence
Our competitive intelligence consulting services are focused in the following areas:
- Tracking industry news, particularly with respect to molecular diagnostics and personalized medicine
- Analysis of key trends in industry-related basic science, translational science, clinical research, and medical practice
- Analysis of key trends in regulation of molecular diagnostics and personalized medicine
- Analysis of key trends in business and financial aspects of the molecular diagnostics and personalized medicine arena
Venture Capital Advisory Services
If you are considering an investment in a biotech or device company, we can assist you in rigorously evaluating the current science supporting the potential product's clinical utility - which, in today's cost conscious environment, will generally be a key driver of commercial success. For more information regarding our venture capital/due diligence-related services please contact us.
Services for Payers, Managed Care Organizations, and Genetic Benefit Management Companies
If you are interested in information about our services in this area, please contact us.
