Strategic Consulting

Strategic Consulting

Our statisticians can assist on every step of your trials from start to finish to facilitate faster and easier regulatory approval. 

We can help you with: 

  • Statistical Review 
  • Microbiome Analysis 
  • Statistical Analysis Plan 

Statistical Review

Our group of statistical experts reviews the various aspects of clinical trial that require statistical analysis.  

This includes the review of:  

  • Statistical aspects of the protocol  
  • Power and Event Calculations 
  • Writing the Statistical Analysis Plan (SAP)  
  • Statistical outputs comprising tables  
  • Figures and listings  
  • Abstracts  
  • Posters and manuscript  
  • Design of CRF  
  • Design of database 

Microbiome Analysis

Researchers can analyze large complex microbiome data sets using Big Data technologies and high-level computing resources. New research is being conducted to discover new methods and tools for analyzing microbiome data. 

Prioritizing the factors like  

  • Analysis of microbiome data and tools to explore its composition  
  • Longitudinal data analysis  
  • Causation Analysis  

 

The data scientists at Genpro explore the possibilities of developing a dynamic software framework using Angular JS, SAS®, R, Python® and Rasa NLU for easy and effective analysis of microbiome data sets. 

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Statistical Analysis Plan

The creation and writing of this document can be time consuming and laborious. Genpro’s statisticians can easily take these activities working closely with our sponsor prioritizing the factors like  

  • Study objectives,  
  • Study endpoints,  
  • Trial population, design of the trial, sample size calculations,  
  • Randomization methods,  
  • Statistical methods, Missing data handling techniques etc.  

 

The statistical approach employed, such as efficacy analysis, safety data analysis, and reporting norms, is also thoroughly described in SAPs. We send the material to the review board and the authorities after evaluating it. The modifications to the procedure will also be made.