Biostatistics

Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout the entire clinical development process. Biostatistics is at the heart of every clinical study—driving study design, study conduct, data collection, analysis and reporting—and our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis.

Our Statistical Experience

We have extensive experience providing biostatistical consulting  and services from study design and protocol development to study analysis through regulatory submission and agency meeting representation.  Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.

Engage our biostatisticians to support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects.  Or, partner with us to make our biostatistical team your team. 

biostatistics CRO

Explore Our Biostatistic Services 

  • Study design  
  • Protocol development
  • Strategic statistical consulting
  • Sample size calculations
  • Endpoint development
  • Randomization schemes
  • Statistical analysis plans (SAP)
  • Adaptive Design clinical trial planning, simulation and implementation
  • Statistical tables, data listings, and figures for clinical study reports (CSRs)
  • eCRF design and review
  • Statistical analyses and reports
  • Pharmacokinetic and pharmacodynamic analyses
  • Regulatory Submissions - Regulatory guidance, planning, and meeting representation
  • Integrated safety and efficacy analyses (ISS/ISE/ISM)
  • Data Monitoring Committee (DMC) services
  • SDTM and ADaM dataset preparation (submission ready dataset packages)

Learn More with These Resources

Webinar Presentation
Achieving Balance in Clinical Trial Database Design

Get the webinar presentation - to understand how to balance the short- and long-term goals of the sponsor, consider the ease of use for the clinical trial sites, and ...

Webinar Video Replay
Achieving Balance in Clinical Trial Database Design

View the webinar replay - to understand how to balance the short- and long-term goals of the sponsor, consider the ease of use for the clinical trial sites, and ...

Case Study
Preparing Data for a Marketing Authorization Application ...

Read the case study to learn how we helped a biotech prepare the MAA submission for a recently acquired product. Our creative approach included utilizing one DB for ...

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