EXTRAPOLATE . . . has a proven record of client success in providing the FDA with biostatistical analysis sections of protocols, statistical reports, and technical oral presentations. We design and analyze clinical trials for pharmaceutical, device, and biotech industries, and write results for publication. EXTRAPOLATE ’s experience includes the design and analysis of studies for biologics, devices, and pharmaceuticals. Our analyses of clinical research trials have generated reports and presentations acknowledged favorably by the FDA, and by industry sponsors in the United States, Germany, France, and Japan. With our help, clients have published manuscripts and have received approval from the FDA for their drugs and medical devices.
Our biostatistics contract research organization provides expert help and personalized service involving sample size determination, variable and fixed block randomization, stratification and other methods to minimize bias, stopping rules, and imputation of missing data. We analyze medical and survival outcomes, as well as recurrent event and competing risks. Other outcomes include cost, quality of life, healthcare utilization, survival, and patient reported outcomes. Call us: 203 273 STAT (7828).
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- We develop clinical trial protocols to evaluate relative efficacy and safety.
- Our study designs minimize bias.
- We derive sample sizes and provide tailored randomization schemes.
- We provide clearly written statistical reports, with graphical illustrations of model assumptions and results.
- Our statistical analysis methods include descriptive, multiple linear and logistic regression, as well as more advanced multivariate statistical models including hierarchical, and single and multievent survival models.
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Our depth of expertise in the following areas allows our research designs
to stand up to the most stringent FDA and peer review scrutiny:
- cardiology
- infectious diseases
- neuro-oncology
- ophthalmology
- pediatrics
- radiation oncology
- pulmonary medicine
- pharmaceuticals
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- critical care medicine
- nephrology
- nursing
- orthopedics
- public health
- rehabilitative medicine
- surgery
- device clinical trials
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- geriatrics
- neurology
- occupational medicine
- otolaryngology
- radiology
- plastic and reconstructive surgery
- substance abuse
- pharmacoeconomic analysis
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We will gladly meet you at your site to discuss the design and analysis of your clinical research projects.
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Data and Safety Monitoring Board Membership
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Dr. Freeman has extensive experience as a member and Chair of data and safety monitoring boards that monitor clinical trial data for industry-sponsored pharmaceutical and device clinical trials. She currently Chairs an NIH sponsored data and safety monitoring board for a clinical research trial and serves as its biostatistics resource.
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