Programming and Biostatistics

Statistical Analysis

REGISTRAT-MAPI statisticians understand that every project is unique and requires different levels and types of statistical analysis. The following list highlights typical statistical needs of Sponsors:

  • Repeated measures analysis
  • Multivariate analysis
  • Covariate-adjusted analysis
  • Survival analysis
  • Categorical data analysis
  • Univariate and bivariate summary statistics reporting

Regardless of the type and level of analysis chosen, the REGISTRAT-MAPI Biostatistics group is dedicated to providing superior service in the communication of statistical results. The Biostatistics group has collaborated with researchers of differing experience levels and is committed to communicating results in a clear and understandable way, including:

  • Writing and reviewing statistical methods sections of manuscripts
  • Preparing abstracts, posters, and presentations
  • Preparing tables and figures for publication
  • Developing protocols
  • Reviewing CRF and study materials
  • Developing a Statistical Analysis Plan

Statistical Programming

REGISTRAT-MAPI's programmer analysts have a wide array of experience using SAS® to generate analyses and custom report displays for our Clients. REGISTRAT-MAPI's programming staff works closely with the Sponsor, Biostatistics, Data Management, and Project Management personnel to produce consistent, high-quality results. Our programmers generate and maintain all code for statistical analyses of clinical data, safety summaries, and health economic projects.

REGISTRAT-MAPI programmers perform independent dual code development to ensure maximum accuracy. They also provide input into CRF design, annotation of CRFs, Data Management Guidelines, Data Analysis Plans, Safety Narratives, and Clinical Study Reports. REGISTRAT-MAPI can also prepare custom Patient Data Summaries and metrics to assist Investigators in practice management.

Programming Services

  • Design of presentation-ready site reports with graphic data displays
  • Creation of custom analysis datasets based on Sponsor requirements
  • Programming of data edits for data cleaning
  • Generation of automated data reports
  • Programming of special requests and analyses
  • Data transfers
  • Generation of site payment and custom site payment reports
  • Site selection through categorization and mining of large site information data sources
  • Site communication support through preparation of custom blast faxes and emails, and Site Data Reports

Our sponsors and sites, alike, have used the Site Data Reports to identify gaps in care and therapy, both overall and at a site level. All of this is designed with efficiency in mind and the ability to broadcast to hundreds or thousands of sites at the push of a button. Over the past 10 years we have delivered over 10,000 Site Data Reports to approximately 1,500 sites.