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PUTTING IT PERSPECTIVE

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BIOSTATISTICS

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CurAccel’s Biostatistics services provide high-quality deliverables for your regulatory strategy, clinical protocol plans, data analysis, and clinical reporting.  Establishing an analytical approach with an experienced biostatistician who can guide and navigate a highly regulated and evolving environment is critical.  As a result, CurAccel assigns a biostatistician with a deep understanding of regulatory requirements at specific therapeutic areas.  Our strong validation and quality control procedures will enhance the accuracy, speed, and flexibility of our reporting.

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CurAccel can operate as a functional service provider or as a standalone provider.  At a minimum, our Biostatistics service offerings are:

  • Statistical Analysis Plan (SAP) development, including sample size calculation, analysis methods, data displays, and interpretations

  • Randomization codes

  • Derived datasets (design, development, and validation)

  • Tables, Listings, and Figures (TLFs) (design, development, and validation)

  • Statistical analysis report for interim analysis and final study report

  • Patient profile reporting

  • Data Safety Monitoring Board (DSMB)

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