Statistical Programming

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Statistical Programming

At CliniOps we offer you high-quality, cost-effective, best in class biostatistics services. We have rich experience in biostatistics analysis & reporting. Our biostatistics services offer you accurate data analysis and the ability to comply with regulatory requirements. Our services include all activities right from Trials Design to Randomization to Statistical Programming to Tables, Listings and Figures (TLFs) to Clinical Study Report (CSR) submission. We have extensive experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes and global infrastructure. Our deep regulatory knowledge & domain expertise in biostatistics services helps you to navigate the complexities of study design, calculation of sample sizes, study randomization, Data Visualization etc. Our comprehensive biostatistics services include:

Statistical Analysis Plan (SAP) creation and setup

Statistical Analysis Plan (SAP) creation and setup:

  • For any phase of drug development, our highly experienced biostatisticians and programmers work closely with the study team to develop study design, perform sample size calculation and power determination, develop randomization scheme, write statistical analysis section of protocols, and write SAP detailing statistical methodologies. The SAP includes detailed descriptions of data consistency checks, data listings, and tables and graphs. Our professional programmers create and finalize programming processes for data consistency checks, data listings, and graphics.

  • Statistical Analysis and Programming

    Statistical Analysis and Programming:

  • We offer comprehensive statistical analysis services such as interim statistical analysis for adaptive designs and data and safety monitoring boards (DSMBs), data analysis for preparing integrated study reports, exploratory analysis for publications, abstracts, and marketing, and analysis of non-clinical trial data from epidemiologic studies and pre-clinical studies.

  • Reporting

    Reporting:

  • Our seasoned biostatisticians are committed to excellence in preparing your statistical reports, writing statistical sections of clinical study reports, writing statistical sections of integrated study reports, and writing statistical portions of manuscripts.