STATISTICAL PROGRAMMING

 

Statistical Programming breathes life into clinical trials by allowing data to speak via high throughput and rapid data analysis, much of which wouldn’t be possible without effective and accurate statistical programming.

K3-Innovations’ team of Biostatisticians and Statistical Programmers have comprehensive knowledge and are SME of various therapeutic areas. Our core teams have thorough knowledge and experience working through various submissions and regulatory standards. We support AD hoc analysis, exploratory analysis, BLA submissions, NDA submissions, ISS/ISE submissions etc. Our teams have worked in all phases of clinical drug trials and on projects of various sizes. The biostatisticians and statistical programmers at K3-Innovations collaborate with clients to offer insightful analysis and customize data programs to fit their requirements. No matter the size and phase of your study, our work is completed with the utmost precision and accuracy

 

Our team follows validation steps as per our SOP to ensure the highest level of quality in every phase of programming and data reporting. Our team of Experienced professionals offer technical support for your most innovative and complex trials, working closely with other cross functional teams including data management, biostats, medical writing etc. End-to-end services and collaboration guarantee the efficiency and accuracy of your study. We heavily use SAS® to ensure FDA compliance activities. Our team also has R and Python experience and use this experience when needed by our clients.

 

  • Randomization and IWRS development

  • xml files, Open CDISC report, Review Guide

  • Annotated TFLs

  • CDISC compliant Analysis datasets

  • TLF programming

  • Complex cross-tabular edit checks

  • Data cleaning programming of key
    safety and efficacy endpoints

  • Submission-ready package

  • ISS and ISE Data Integration and Analyses

  • Safety report and IB support

  • Project reports

  • Macros and in-house tool development

Reporting Macro Suite

 

Our validated reporting macro suite written in SAS® enables the creation of high-quality and consistent tables, listings, and figures using SDTM and ADaM datasets. This suite of macros helps to cut down programming time by half. The macros are also written so that there is a flexibility to include custom code when needed. The beauty of these macros are that you have less programming to worry about since it is metadata-driven while you worry about other changes that are occurring in the study during the long path towards submission.

Get in touch with us today and let us know how we can help you

©2020 by K3-Innovations Inc. All Rights Reserved.  

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379 Princeton Hightstown Road,
Building 2 Suite 2,
East Windsor, NJ 08512
+1 732 645 8366
+1 732 596 7523

©2020 by K3-Innovations Inc. All Rights Reserved.