Statistical Services

 Our biostatistical services cover:

• In-vitro and in-vivo bioequivalence studies: standard ABE/ PBE analysis and “what-if” simulation studies
• Dissolution studies: f2 bootstrap, MSD model dependent and model independent methods, best method/model selection/assessment, justification studies
• Clinical trials: tabulation, graphical presentations, comparison of means, proportions, odds and risks, linear regression and correlation, logistic regression, Poisson regression, multivariate analysis, survival analysis, etc.
• Data irregularities/forensics analyses of clinical trials data
• Advanced ad-hoc studies: Simulation/ Monte Carlo studies, Monte Carlo and randomization tests, bootstrap, outlier identification and analysis, etc.
• QC/QA reporting requirements: stability analysis, microbiological environmental monitoring, analysis and reporting (air, water, machines), FMEA analysis, DOE, etc.

Why should you use our services?

• Established statistical expertise
• Validated SAS programs and procedures
• Statistical report preparation following our strict standard operating procedures
• Urgent turn-around times
• Tailored training in statistics
• Consultation services geared to the client's level of expertize

Cair Center has accumulated vast experience in several therapeutic areas including respiratory diseases, allergy, asthma, oncology, gynecology ,etc.

Our primary tasks have been to participate in successful global regulatory submissions by taking responsibility for statistical analysis, data management, and preparation of statistical reports on a timely bases.
Occasionally we participate in meetings at the EMA and write expert reports.

Currently, we are participating in several drug development projects aimed at regulatory submissions. 

Useful links:

FDA Guidances (link):

Non-Inferiority Clinical Trials to Establish Effectiveness 

Statistical Approaches to Establishing Bioequivalence

Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action 

FDA Draft Guidance on Budesonide

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations

EMA Guidances (link):

ICH (link):

Statistical Principles for Clinical Trials (ICH E9)

More about CAIR CENTER IN-VITRO BIOEQUIVALENCE STUDIES:

• CAIR CENTER IN-VITRO BIOEQUIVALENCE STUDIES