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Trial Runners Biostatistics and Programming Team- An Overview

A perfectly aligned Biostatistics and Programming team is worth its weight in gold. In clinical research, it can be costly if these 2 functional teams are not collaborative and aligned- possibly impacting operational efficiency, data integrity and data quality. Trial Runners’ in-house B&P team maintains a clear focus on obtaining high quality data, which reduces the overall time from drug development to market.

But what does the Trial Runners Biostatistics and Programming team deal with? What do they aim to deliver? We took a quick peek into their world.

 

Biostatistics & Programming

The Biostatistics and Programming team provides operational statistics for all phases of clinical research and drug development.

Our Biostatisticians and Programmers collaborate to jointly deliver a variety of services including, but not limited to:

  • Design of clinical trials and product programs
  • Statistical Analysis Plan (SAP) development
  • Data analysis planning and Protocol development
  • Sample size & power calculations
  • Interim & Final Statistical analyses
  • Data package development with validation of tables, listings & figures (TLFs)

The Biostatistics and Programming team also coordinates with our Data Management team to assist with Case Report Form (CRF) development and dataset specifications.

Our team members work closely with medical writers to write the statistical part of the Clinical Study Report (CSR) and ensure appropriate interpretation of study results.

 

What roles are involved in Biostatistics & Programming?

Biostatistics & Programming requires a variety of roles and responsibilities of team members and take the form of:

Biostatistician: Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, write the statistical section of the protocol and develop Statistical Analysis Plan.

Lead Programmer: Responsible for delivery of technical components required to support the analysis and reporting for various projects. Efficiently coordinate activities of other SAS programmers assigned to projects. Communicate and negotiate programming timelines to Clinical Trials Teams.

Production Programmer: Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy utilizing SAS programming. Generate SDTM and ADaM datasets and TFLs.

Validation Programmer - Responsible for validating datasets, summary statistics, and other reports generated by production programmer. Develop independent programs and use various methods to ensure results are accurate.

 

Primary Deliverables:

The primary deliverables for Biostatistics & Programming majorly consist of:

  • Statistical Analysis Plan (SAP) and Mock-up Shells
  • SAS datasets (raw data)
  • Study Data Tabulation Model (SDTM) specifications
  • SDTM datasets
  • Analysis Data Model (ADaM) specifications
  • ADaM datasets
  • Validated P21 CDISC compliant data
  • Annotated CRF
  • Define xml for SDTM and ADaM
  • Study Data Reviewers Guide (SDRG) and Analysis Data Reviewers Guide (ADRG)
  • Tables, Listings and Figures (TLFs)

 

Typical Biostatistics & Programming key standards:

CDISC (Clinical Data Interchange Standards Consortium) standards

Study Data Tabulation Model Implementation Guide (SDTMIG)

Analysis Data Model Implementation Guide (ADaMIG)

 

Typical Programming Tools:

Statistical Analysis System (SAS) is widely used in clinical trials for data analysis, reporting and statistics. SAS is considered the gold standard for analysis of clinical trial data.

Trial Runners uses multiple modules of SAS and other enterprise software as follows to accomplish our deliverables:

SAS (STAT/SQL/ODS/MACRO/GRAPH/ACCESS), and Pinnacle21 (formerly known as OpenCDISC Validator) to ensure data is in compliant with CDISC and FDA requirements.

 

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A lot to take in? We agree. Biostatistics and Programming can be overwhelming to those who are unfamiliar. But the good news is, Our B&P team is ready to take on whatever your clinical trial can throw at them.

For more information on our Biostatistics and Programming services, contact us via our website or email at info@trialrunners.com.