Areas of Expertise and Services Offered
Epidemiology
- Observational study design
- Safety signal analysis and review in pre- or post-marketing setting
- Development of documents to support biological license application
Outcomes Research and Quality of Life (QoL)
- Critical technical assessment of existing QoL and patient reported outcomes (PRO) instruments
- Development of protocols to validate new QoL or PRO instruments
- Development of documents to support biologic license application
Health Economics
- Provide epidemiology and scientific input on budget impact models and cost utility analyses
- Summarize published literature to support model development
- Provide sources and estimates for model parameters including population, utilities, costs, adverse events and morbidity and mortality rates
Biostatistics
- Study design, sample size, data handling for clinical studies
- Study reporting requirements
- Statistical method development and simulation
Data Services
- Definition of SAS analysis datasets
- Statistical analysis and reporting for clinical trials
- Data Monitoring Committee (DMC) support
Scientific Writing
- Literature reviews
- Study reports, scientific publications and communications
- Regulatory documents
Examples of Services Offered
Literature review of the natural history of disease including estimates of incidence and prevalence of disease of interest
Development of protocols for observational studies to identify safety signals, explore risk factors, factors associated with progression, or treated natural history of disease
Critical technical assessment of existing QoL and patient reported outcomes (PRO) instruments
Development of dossier materials to support inclusion of QoL or PRO data in product labels in biologic license application
Statistical design or review of clinical trials including study design, power, sample size, and data capture
