Leading the way to high-quality, timely analysis-ready data set delivery

Cognigen, a SimulationsPlus company has long stressed the need to address the data assembly challenges of model-based drug development. This project takes a new look at the data requirements specification process in light of the emergence and broad acceptance of CDISC standards. We see first hand, the struggle that companies have in data programming and the delivery of high quality data. Our systematic approach to requirements definition has broad applicability and we would be happy to discuss opportunities to deploy a customized data requisition system for your company.

Comprehensive requirements and an easy to use data requisition system are essential to efficiently create pharmacometric analysis-ready datasets. Requirements are a critical communication tool between modelers and data programmers and are used to ensure the quality of the analysis dataset. Time spent up front preparing dataset requirements has been demonstrated to save significant time later in detecting and correcting inadvertent errors in dataset structure and content when requirements are not defined. Common PK-related and PK/PD therapeutic area-specific requirements with relevant questions intended for use in easily capturing analysis-specific dataset content, structure, and formatting needs are part of the data requisition system

The data requisition system includes planning prompts designed to get the Analyst thinking about important aspects of the modeling to be performed, the study designs of the included studies, and how this information relates to the structure and content of the analysis-ready dataset. The Analyst then selects desired variables from the requirements form. To facilitate variable selection, the analyst can choose the therapeutic area of interest from a list of available therapeutic areas. Selecting the therapeutic area for the pharmacometric analysis automatically populates the requirements with appropriate fields.

Once variables have been selected, the analysis-specific requirements are generated. The selected variables have default labels, units, codes, decodes, and formats which can easily be changed to support an analysis. The analyst can also select imputation methods for each relevant variable from a list of potential imputation strategies. Once the Analyst completes the requirements, the information is delivered to the data programmer. With these clear and concise requirements in hand, programming time is reduced and quality of the resulting analysis-dataset increased.

Over the past 25 years, Cognigen, a SimulationsPlus company has developed and formalized a systematic process for the assembly of data to support pharmacometric model development efforts. In regularly working with multiple clients on numerous compounds in a variety of different therapeutic areas, we have developed robust dataset specifications to handle the many possible variations in data collection, study designs, and data content. These experiences have been distilled into concise requirements forms that ensure the reliable delivery of analysis-ready datasets. As always, the goal is to allow ample time for model development and interpretation of results to support decision-making at critical milestones.

Send us a note or call us at 1.716.633.3463 ext 229 for additional information.

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Leading the way to high-quality, timely analysis-ready data set delivery

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