PharPoint Research

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Biostatistics and Statistical Programming

PharPoint offers industry leading statistical analysis and reporting services through the use of a variety of preferred software including SAS®, StatXact®, and WinNonLin®. Our main focus is to ensure the integrity of your data, organize the results in a clear and compelling presentation, and provide the analysis in timeframe that meets or exceeds our sponsor expectations. These goals are achieved due to a highly talented, motivated, and experienced team whose commitment to sponsor satisfaction is unmatched. We are well versed in industry accepted standards such as those provided by the CDISC organization. Our programming model provides the flexibility to implement standards such as SDTM as well as 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 our sponsor. Our responsiveness to sponsor needs is unprecedented. In fact, time from database lock to delivery of verified SAP defined output is generally 5 to 7 business days. Top line results can be delivered in 1 to 3 business days.

PharPoint provides the following biostatistics and analysis programming services:

Strategic Product Development Consulting
  • Protocol Development
  • Sample size Planning and Power Calculation
  • Randomization Planning
  • Regulatory and Advisory Meeting Support
  • Special Protocol Assessments (SPAs)
  • Statistical Analysis Plans
Statistical analysis and support services for interim, futility, and DMC analyses
  • Assistance with committee composition
  • Preparation of the DMC charter
  • Generation of the analyses
  • Statistician representative at the meetings
  • Preparation of the meeting minutes
  • Provide conditional power and sequential analysis methods
  • Adaptive designs, and other specialized statistical techniques
Preparation of Statistical Portions of Regulatory Submissions
  • Integrated summaries ( safety and efficacy)
  • Preparation of case report tabulations (CRTs)
Analyses provided in a variety of formats
  • Individual DOC, RTF, and PDF files
  • Single hyperlinked PDF file
Quantitative epidemiology including patient registries Data mining/exploratory analyses