Clinical Services > Biostatistics

Biostatistics

 

Biostatisticians plays a key role in the planning and preparation of any clinical study. Our stats team can support every step of the process, from designing a cost-effective, optimal clinical study to providing the relevant statistical input on the study protocol to present it to the FDA and other regulatory agencies.

Key advantages to partnering with PRC Clinical™ include:

  • Extensive libraries of standard Table, Listing, & Figure (TLF) summaries
  • Proficiency in converting data into SDTM standards
  • Seamless interaction between Biostatistics and Clinical Operations teams at PRC
  • Efficient delivery of top-line full analysis packages following database lock
  • Full SOPs (Standard Operating Procedures)

Biostatistics Services Include:

  • Power and Sample Size Calculations
  • Study Design & Endpoint Development
  • Client Representation at Regulatory Agency Meetings
  • Randomization Schedule Preparation
  • Statistical Analysis Plan Development
  • Interim Analysis Planning
  • Data Monitoring Committee Planning and Reporting
  • SAS Programming and Independent Validation of TLFs
  • Meta Analysis/Post Hoc Analysis
  • Pharmacokinetic (PK) Analysis
  • Review and Support for Publications
  • Integrated Summaries of Safety & Efficacy (ISS/ISE)
  • CDISC SDTM and ADaM Standards
  • SAS-Derived Data Review and Interpretation Tools (i.e. Patient Profiles & P-Value Summaries)