Areas of Expertise and Services Offered


  • 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


  • 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

While overall mortality rates drop in the US, poor rural counties still struggle with infectious disease deaths
An investigation into the trends and patterns of infectious disease mortality rates in the US shows that while mortality rates have declined 18% overall, there is a disparity in the rates of decline between urban and rural counties. The study, published in JAMA, suggests as much as a 20-year spread [more]
Study suggests the use of statins may help prevent dementia
Results of a systematic review and meta-analysis to investigate the possible associations between the use of statins and the risk of all-caused dementia, Alzheimer's diseases(AD), vascular dementia (VaD), and mild cognitive impairment (MCI) have been published in Nature Scientific Reports online. The results of twenty-five relevant studies suggest that [more]
Protein from meat is bad, but proteins from nuts and seeds are good for your heart says Adventist Health Study
Researchers in California and France have found that consuming high amounts of meat protein increases the risk of cardiovascular disease (CVD) by as much as 60 percent, while a high intake of protein from nuts and seeds decreases the risk of CVD by 40 percent. The study, published online by [more]
CMD Consulting, Inc.