Our Services

Comprehensive Consulting Services

We provide end-to-end biostatistical and clinical research consulting tailored to the needs of medical device, IVD, and pharmaceutical companies.

1

Clinical Trial Design & Execution Support

  • Protocol development and optimization
  • Sample size and power calculations
  • Endpoint selection and composite endpoint design
  • Adaptive and Bayesian trial designs
  • Randomization and blinding strategies
  • Data monitoring committee (DMC) charter development
  • Interim analysis planning
  • Clinical study reports (CSR) authoring
2

Biostatistical Analysis

  • Statistical analysis plans (SAP)
  • Primary and secondary endpoint analysis
  • Survival analysis and time-to-event methods
  • Bayesian and frequentist approaches
  • Missing data handling strategies
  • Multiplicity adjustment methods
  • Meta-analyses and systematic reviews
  • Real-world evidence (RWE) analytics
3

Regulatory Evidence Generation

  • FDA 510(k), PMA, and De Novo submission support
  • Clinical evaluation reports (CER) per EU MDR
  • Pre-submission (Q-Sub) meeting preparation
  • Breakthrough Device Designation strategy
  • Risk-benefit analyses for regulatory submissions
  • Post-market clinical follow-up (PMCF) plans
  • Literature review and evidence gap analysis
  • Predicate device comparison strategies
4

IVD Product Validation

  • Analytical performance study design (sensitivity, specificity, precision)
  • Clinical performance evaluation planning
  • Method comparison and agreement studies
  • Reference interval studies
  • Interference and cross-reactivity testing protocols
  • Stability study design and analysis
  • CLSI guideline-aligned study protocols
  • Multi-site clinical validation studies
5

Publication & Communication Support

  • Manuscript preparation for peer-reviewed journals
  • Conference abstract and poster development
  • White paper and technical report authoring
  • Results interpretation and clinical significance narratives
  • Statistical methods sections for publications
  • Systematic literature reviews

Have a project in mind?

Let's discuss how our expertise can support your regulatory and clinical development goals.

Contact Us