Whether your clinical trial is in the planning stages, or you need biostatistics support for an existing study, DataCeutics' expert biostatisticians can help. Our biostatistics team has extensive clinical trial experience across multiple therapeutic areas. Additionally, the vast majority of our biostatisticians hold advanced degrees in biostatistics, mathematics, or clinical disciplines.

 
 

Biostatistics From the Beginning: Developing a Statistical Analysis Plan

The Statistical Analysis Plan (SAP) keeps the study team focused on achieving the same goals during the study and development process.

For the Sponsor

The Statistical Analysis Plan (SAP) ensures the accurate output needed for the Clinical Study Report (CSR) and FDA Submission.

For the Programmer

The SAP defines the required SAS programming and presentation of the tables, listings and figures.

For the Biostatistician

The SAP defines all statistical methods and analysis to be output in the Clinical Study Report (CSR).

 

Our Statistical Analysis Plan (SAP) services include CSR Statistical Analysis Plans, Interim Statistical Analysis Plans, Data Safety Monitoring Board (DSMB) Statistical Analysis Plans and Integrated (ISS, ISE) Statistical Analysis Plans.

We will work with you to develop:

  • Primary and Secondary Objectives

  • Sample Size and Power Estimation

  • Randomization and Blinding of Sponsor Team

  • Global Definitions and Conventions, Analysis Windows

  • Rules for handling Missing Data

  • Definitions of Populations: Efficacy-evaluable, Intention-to-Treat (ITT), Safety and other sub-groups

  • Interim Statistical Analysis

  • Demographics and Baseline Characteristics

  • Subject Disposition and Compliance to Study Treatment

  • Method for Analysis of Efficacy Endpoints

  • Evaluation of Safety Parameters

 

Biostatistics Services

DataCeutics can be your single-source biostatistical service provider, or augment your existing team. Our service structure and FSP model provides your company the flexibility to obtain best-fit support that aligns to your study and your business. We provide the following biostatistical services.

  • Statistical Analysis Plan (SAP) Development

  • SDTM Dataset Programming and QC

  • TLFs Shell Development

  • TLF Programming and QC

  • PDF and Bookmarked Version of Final TLF Delivery

  • Analysis Dataset Specifications Development and Implementation

  • Data Edit Check Programming

  • Clinical Statistical Report (CSR) Development

  • Define files for SDTM and ADaM Generation

  • DSMB or Interim Analysis Development, if needed

  • Data Transfer (including all the programs to enable recreation of datasets and analysis)

  • Regulatory Agency Meeting Client Representation

Do you need other specialized biostatistical support? Contact us today to speak with a member of our team about your specific needs.   

Expert Biostatisticians


Dr. David Lombardi - Senior Statistician

Dr. David Lombardi
Senior Statistician

Dr. Eva Miller -  Senior Statistician

Dr. Eva Miller
Senior Statistician