Our Services

Consulting Services

We provide biostatistical and clinical research consulting for medical device companies and clinical research institutions.

1

Clinical Study Design

Protocol development for prospective and observational studies
Sample size and power calculations
Endpoint selection and outcome measure design
Multi-center study coordination and site activation
Randomization and blinding strategies
IRB application preparation and submission management
Informed consent form development
Direct liaison with IRBs on behalf of investigators
Study protocol, case report forms, and SOP development
Clinical study reports (CSR) authoring
Regulatory and ethical compliance (IRB, GCP, HIPAA)

2

Biostatistical Analysis

Statistical analysis plans (SAP)
Primary and secondary endpoint analysis
Survival analysis and time-to-event methods
Bayesian and frequentist approaches
Latent class analysis and machine learning methods
Missing data handling strategies
Meta-analyses and systematic reviews
Data analysis in R and Python

3

Evidence Generation for Medical Devices & Diagnostics

Clinical utility and health economic outcomes research (HEOR)
Diagnostic performance evaluation (sensitivity, specificity, precision)
Biomarker validation study design and analysis
Method comparison and agreement studies
Clinical evidence packages for regulatory submissions
Post-market clinical follow-up study design
Literature review and evidence gap analysis
Medical literature synthesis and critical appraisal

4

Publication & Scientific Communication

Manuscript preparation for peer-reviewed journals
Statistical methods sections for publications
Conference abstract and poster development
Publication strategy development
Results interpretation and clinical significance narratives
Systematic literature reviews

Have a project in mind?

Let's discuss how we can support your clinical research and evidence generation goals.