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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:

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Meet your requirements and specifications by being diligent and meticulous.

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Provide accurate, reproducible results by validating the software that we develop.

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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

NDA /MAA/BLA
  • SAPs for Integrated Summaries
  • Statistical Analyses for Integrated Summaries
  • Writing/Reviewing of Statistical Sections of Integrated Summaries
  • Reviewing of Clinical Summary and Clinical Overview
  • Reviewing other sections as necessary
  • QC efforts verifying accuracy of results of applicable CTD sections
PMA
  • Writing/Reviewing Overview Section
  • Writing/Reviewing Clinical Data and Information Section
  • Writing/Reviewing Summary of Safety and Effectiveness Section
  • Reviewing Directions for Use Section
  • Reviewing other sections as necessary
  • QC efforts verifying accuracy of results of applicable PMA sections
510(k)
  • Writing/Reviewing Performance Testing – Clinical Section
  • Reviewing Substantial Equivalence Discussion Section
  • Reviewing Proposed Labeling Section
  • Reviewing other sections as necessary
  • QC efforts verifying accuracy of results of applicable 510(k) sections
Regulatory Response
  • Face to Face meetings
  • Teleconferences
  • Written Communications
  • Phase IV/Post-Approval Study planning
Advisory Committee Support
  • Strategy/Planning of Key Messages
  • Developing Q&A materials
  • Conduct Adhoc Analyses

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
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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.

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