Our biostatisticians play a crucial role in the development and execution of clinical trials and research projects by ensuring robust statistical methodologies, maintaining data integrity, and providing clear, actionable insights. Our expertise spans a variety of study designs and statistical analyses, backed by proficiency in industry-standard software (SAS, R) and adherence to regulatory requirements.

Our Expertise:

1. Design Phase
   • Endpoint Selection
     • Identifying primary and secondary endpoints
   • Sample Size Calculation
     • Using SAS and R for precise sample size determination
   • Analysis Methods
     • Selection of appropriate statistical methods
   • Analysis Populations
     • Defining and understanding target populations
2. Analysis Phase
   • Data Review and Cleaning
     • Ensuring data accuracy and consistency
   • Statistical Programming
     • Using SAS, R, and Python for comprehensive data analysis
   • Validation of Statistical Assumptions
     • Confirming assumptions and accuracy of results
3. Reporting Phase
   • Result Interpretation
     • Making statistical outcomes understandable and actionable
   • Reporting Standards
     • Adhering to regulatory requirements in reporting
   • Communication with Stakeholders
     • Effectively communicating results to diverse audiences
4. Expertise and Experience
   • Study Designs
     • Experience with crossover, parallel, full replicate, partial replicate, two-stage design, and patch studies
   • Regulatory Compliance
     • Expertise in clinical patient PK analysis, CSR preparation, and regulatory protocols
   • Software Proficiency
     • Proficient in SAS, Phoenix WinNonlin, and other analytical tools