Areas of Expertise and Services Offered

CMD Consulting provides epidemiologic and Outcomes Research services for a wide range of biotech and pharmaceutical clients. Specific consulting services include:

Epidemiology

• Estimate incidence and prevalence of disease
• Support the design and development of observational, qualitative, and real-world evidence studies within clinical programs, including conducting interviews with healthcare providers to inform market access
• Patient-centered clinical outcomes assessment (PCOA) strategies following regulatory guidance, including commercial and market access considerations
• Evaluate existing or build new conceptual disease models of the patient experience
• Determine responsiveness and meaningful change thresholds
• Summarize the competitive and regulatory experience of potential outcome measures
• Development of documents to support biologic license application
• Establish evidence and rationale to demonstrate that PCOAs meet regulatory guidance
• Literature reviews to support all phases of clinical development, including development of target product profile, clinical trial study design, and product launch

Health Economics and Outcomes Research

• Provide epidemiology and scientific input on budget impact models and cost utility analyses
• Development of population models
• Provide sources and estimates for model parameters, including population, utilities, costs, adverse events, and morbidity and mortality rates

Scientific Writing

• Develop and provide content and writing support for patient-reported outcome evidence dossiers, including AMCP dossiers for new molecules
• Write publications for submission to peer-reviewed journals to support publication of patient-centered outcomes for clinical trials
• Write abstracts for reporting results of real-world evidence studies and patient-centered outcomes in clinical trials for presentation at scientific conferences
• Develop and write internal study reports