Biostatistics

Biostatistics and statistical programming services

PharPoint’s biostatistics department offers a wide range of services designed to meet the needs of each clinical trial. 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. Throughout a study, PharPoint biostatisticians work closely with the entire project team to ensure data are correctly captured and ready for analysis.

Guided by experience & expertise

PharPoint understands that a good team is what makes a great service provider, and our biostatistics team is great at what they do. In addition to substantial clinical experience in statistics, each PharPoint biostatistician has an advanced degree (Master’s or PhD). Our team has experience supporting regulatory approval submissions and has provided statistical representation across 12 FDA divisions.

%

of our biostatisticians have advanced degrees (Master’s or PhD)

We’ve provided statistical representation across

FDA divisions

Why choose PharPoint Research?

Unlike many “big-box” CROs, PharPoint 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 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.

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.

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.

Our comprehensive clinical biostatistics and 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

Meet a PharPoint Biostatistician

Amy Flynt, PhD, Senior Director of Biostatistics & Consulting Operations

Dr. Flynt received her PhD in statistics from North Carolina State University and has worked for both CROs and pharmaceutical companies since 1998.

Dr. Flynt has served as the lead statistician for Phase 1-4 clinical trials to provide statistical support and successful NDA submissions, including pharmaceutical industry-sponsored pregnancy registries. Additionally, she has served as a voting and non-voting DMC statistician, provided statistical analysis plans and analyses for both a patent application and a new diagnostic tool, participated in the development and validation of a new PRO, and provided FDA representation for multiple sponsors.