PROGRAMMING

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“Programs must be written for people to read, and only incidentally for machines to execute”

Harold Abelson

 

We offer a variety of statistical programming services to facilitate your needs. Our staff will walk you through our process so that we can, together, determine which of our individual or combined programming services will help you to reach your goals. 

Programming Services:

CDISC Compliant Submission Deliverables:

+     SDTM Domains

+     ADaM Analysis Datasets

+     Define.pdf and Define.xml 

+     Study Data Reviewer’s Guide

+     Analysis Data Reviewer’s Guide

+     Tables, Listings, and Figures

Statistical Programming Consulting in support of:

+     Clinical Study Reports

+     Interim Analyses

+     Integrated Summaries

+     Regulatory Submissions

+     Data Monitoring Committee Meetings

Additional Services Provided: 

+     CRO Management

+     Staff Augmentation

+     Complete Biostatistics Staffing

+     SOP/Process Review and Optimization

 

STATISTICS

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"It takes less time to do a thing right than to explain why you did it wrong." 

Henry Wadsworth Longfellow

 

Getting your output correct the first time is our priority. We know that making errors and performing endless updates slows down your timeline and burdens the process. We work diligently on a variety of statistical services with an eye toward precision.

Biostatistics Services:

+     Clinical Development Planning

+     Power / Sample Size Estimation 

+     Protocol Development 

+     Statistical Analysis Plans

+     Interim Analyses / DMC

+     Annual / Periodic Reporting

+     Statistical Modeling / Exploratory Analyses

+     Statistical Reporting and Publications

+     Clinical Study Reporting

+     ISS / ISE / Meta Analysis

+     Due Diligence Support

303 West Lancaster Avenue, Suite 320

Wayne, Pennsylvania19087

info@tradecraftclinical.com

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