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
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.
Dr. David Lombardi
Dr. Dean Leonardi