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Biostatistics Services

Custom developed and designed programs

At PharPoint, we offer leading statistical analysis and reporting services through the use of industry preferred software including SAD®, STatXact®, and WinNonLin®. These programs ensure the integrity of your data, organize results in a clear and compelling presentation, and provide the analysis in a timeframe that meets or exceeds expectations. We’re well versed in industry-accepted standards such as those provided by the Clinical Data Interchange Standards Consortium (CDISC) organization. Our programs provide the flexibility to implement Standard Data Tabulation Model (SDTM) of clinical data and sponsor-preferred standards to both pre-existing databases and those in development. All programs are custom developed, independently verified, and designed to be portable for transfer and use by the sponsor.

Customized SAS Programming

Our system 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

PharPoint's in-house Data Monitoring Committee (DMC) support uses past experiences to benefit each study, providing consistent overhead and real-time updates to reduce delays and provide accurate study outcomes. The biostatistics team works directly for the DMC in preparation for the lockdown of a study.

Consistent Output

Unlike many "big-box" CROs, PharPoint creates documents specific to the sponsor every time—without the use of template macros. When necessary, PharPoint can ensure the study we're working on matches output from previous studies.

Unlike many CROs, PharPoint requires all of our biostatisticians to have a masters or PhD in statistics. At PharPoint, we know stats.

  • 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

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.