Biostatistics and Statistical Programming Services

From start to finish, PharPoint guarantees high quality statistical analysis and reporting services, and can assist with any combination of services needed at the clinical development stage. PharPoint’s biostatistics team works closely with the entire project team throughout a study to ensure data are correctly captured and ready for analysis.

 

Our comprehensive biostatistics & statistical programming services include:

  • Strategic product development consulting
  • Sample size planning and power calculation
  • Randomization
  • Regulatory and advisory meeting support
  • Data mining/exploratory analyses
  • Statistical analysis plans (SAP)
  • Statistical analysis and support services for interim, futility, and DMC analyses
  • Full DMC support
  • Integrated summaries of safety and efficacy
  • Preparation of case report tabulations (CRTs)
  • Quantitative epidemiology including patient registries

30+
Successful Regulatory Submissions

ALL
Biostatisticians have advanced degrees

Customized SAS Programming

Unlike many “big-box” CROs, PharPoint’s biostatistics team creates custom SAS® programming specific to the sponsor every time—without the use of template macros. When rescuing a study, PharPoint can ensure the study we’re working on matches output from previous studies for that program.  Additionally, the programming is designed to work seamlessly with the sponsor’s in-house SAS software, and is provided to the sponsor for use outside of PharPoint. Costs for programming are provided upfront, with no extra charge for sponsors to take study specific programming off-site.

In-House DMC Support

PharPoint’s experience providing in-house data monitoring committee (DMC) support includes the delivery of the entire analysis and administrative management of the committee. Our biostatisticians have participated as the unblinded statistician and/or as the voting/non-voting statistician in a large number of unique protocols.

Standardization of Study Data for Submission

PharPoint uses the SDTM and ADaM standards as the starting platforms for statistical programming.  We have experience mapping data from legacy studies to these standards for submission to regulatory authorities. Our programmers and statisticians will ensure your data conform to the latest regulatory guides.

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