Outsourcing Solutions
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Statistical Programming
SimulStat offers statistical programming services for situations when you have a project that your infrastructure cannot support. SimulStat has expert knowledge of the FDA Electronic Submission Guidelines and the CDISC data model that is endorsed by the FDA. We have many years of experience in creating individual study reports or integrated reports such as ISS, ISE or 120 Day Safety Updates for both NDAs and BLAs.
We can perform any of the following as individual tasks or as a full suite:
Create individual study or integrated analysis data sets
Create tables, listings and/or figures for individual or integrated studies or submissions
Create SDTM data sets
Create ADaM data sets
Create define.xml
Create validation documentation for all programming related tasks
Adhoc validation of output or programs produced by someone else
Our team is also experienced in developing data set creation and reporting utilities and macros. Developing and implementing standardized utilities and macros can dramatically increase the efficiency of your organization by allowing your resources to focus on the less mundane and more difficult tasks.
No matter what type of project SimulStat works on, we will:
Meet your requirements and specifications by being diligent and meticulous.
Provide accurate, reproducible results by validating the software that we develop.
Become part of your team by working with your managers, programmers, statisticians and medical writers.
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Biostatistics
SimulStat provides statistical expertise supporting product life cycle of leading Pharmaceutical/Biological/Medical Device products. SimulStat can also provide strategic guidance and leadership in statistical aspects of a product life cycle.
Our services include but are not limited to the following:
Clinical Studies
Create individual study or integrated analysis data sets
Create tables, listings and/or figures for individual or integrated studies or submissions
Create SDTM data sets
Create ADaM data sets
Create define.xml
Create validation documentation for all programming related tasks
Clinical Study Report Writing/Reviewing
Clinical Study Statistical Memos Summarizing Results
QC efforts verifying accuracy of results
Regulatory Support
Create individual study or integrated analysis data sets
Additional Supporting Activities
Manuscript/conference presentations support
Preparation for and participating in FDA audits of Clinical Data
Statistical input for product life cycle program planning
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Success
Stories
Start your project today
Fill out the form below and let us know some basic information about your project-based needs. We will get back to you and discuss the specifics.
