Vantage Data Designs biostatisticians and SAS programmers apply their extensive industry knowledge and indication-specific expertise to provide study design concepts, appropriate endpoint identification, protocol sample size, statistical analysis plan development, SAS programming, and statistical analysis.

Areas of our biostatistics expertise that may benefit your project include:

• Representation at FDA Meetings
  • Planning / Strategic Consultation
  • End-of-Phase II
  • Special Protocol Assessment (SPA) discussions
  • Pre-NDA / BLA meetings
• NDA / BLA submission activities
  • Process consultation
  • Define ISE / ISS strategies
  • Pooling of efficacy and/or safety datasets
  • Type of submission – electronic, CDISC, etc.
  • Ongoing communication during review cycle
  • Advisory committee preparation
• Assist Companies Develop Clinical Development Program Strategies
  • Participate in planning meetings
  • Product labeling strategies
• Protocol Development
  • Advise and develop appropriate study endpoints
  • Advise on appropriate clinical study designs
  • Calculate sample size and power
  • Randomization Methodologies
  • Write statistical section of the protocol
• Statistical Analysis Plan (SAP)
  • Separate document from the protocol that provides a detailed description of planned statistical analysis
  • Develop mock table shells
  • Formal sign-off of SAP
• Statistical Analysis
  • Inferential statistical methods
  • Exploratory analysis
  • Data modeling
  • Interim analyses
  • Interpretation of statistical results
  • Create randomization schedule
• Data Monitoring Committee (DMC)
  • Participate as a member
  • Help plan the creation of a DMC team
  • Develop DMC charter
• SAS Programming
  • Summary tables, listings and graphics
  • Statistical analysis using SAS
  • SAS programming validation
  • CDISC requirements (if applicable)
• Medical Writing
  • Clinical study reports (full, synopsis, or abbreviated)
  • ISE / ISS
  • Publications
• Poster presentations at professional conferences
• Participate in due diligence meetings for in-licensing opportunities

Contact Vantage Data Designs today for assistance with your project.