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Biostatistics & Statistical Programming

We provide programming support for almost all Study level activities.

  • Study Design – successful execution of the development plan requires insuring that the required trials are well designed to answer the important and relevant questions.  The following categories cover the broad areas we have found are key to designing successful clinical trials.  

    • Protocols

      • Trial Design (e.g., stratification and randomization techniques)

      • Endpoint Selection

      • Analysis Specification

      • Sample Size

  • Statistical Analysis Plan

    • Statistical Analysis Methods

    • Adjustments

    • Missing Data Strategies

    • Table, Figure and Listing Shells

  • Statistical Programming for Clinical Study Reports (CSRs) – Deft programmers have extensive experience in providing the following to our clients.  On-time delivery of the required analyses and validated programs are our strong suit. 

    • Dataset Creation Compliant with CDISC Recommendations

      • SDTM Files

      • ADaM Files

      • Validation of Derived Variables

    • Programming of Planned Analyses

    • Validation of Summary Tables, Figures and Listings

    • Ad Hoc and Exploratory Analyses

  • Statistical Support of Regulatory Activities – successful interaction with regulatory agencies is a cornerstone of any development project.  Deft brings international experience to the table to assist you with these activities.

    • Briefing Document Preparation and Review

      • Strategy

      • Analyses

      • Materials

    • Filings

      • Strategy Development

      • Review of Filing Materials

      • Responding to Regulatory Requests for Analyses

      • Programming Support

      • Development of Advisory Committee Presentations

      • Labeling Strategy

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  • Meetings with Regulatory Agencies

    • Preparation for Meetings

    • Meeting Participation

    • Response to Regulatory Comments

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  • Clinical Study Reports – clear, concise, and well-written study reports are vital to communicating the results of your studies to a variety of audiences.  Deft can help you with completing these essential tasks. 

    • Meeting and symposia abstracts, posters, and presentations

    • Summarization of Findings

    • Interpretation

    • Report Preparation

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