Supervisor, Data Management Labcorp Madison, Wisconsin, United States
There is an important data engineering dilemma within the nonclinical CRO space. The primary focus is on efficient delivery of quality data to the sponsor for use in regulatory submission in the form of the study report and SEND data package. This can often mean that there are a multitude of challenges to the idea that those data can also be utilized in broader and more complex ways such as the development of predictive models to assist in the interpretation of study data. One of these challenges is obtaining the resources necessary to invest in centralized data warehousing. Currently, study data exist in different systems and different formats making the standardization and compilation of these data a significant task. However, some of that difficulty has already been addressed by the SEND standard making this format a prime candidate for use, especially with the continued growth of the data types that are being brought into scope each year. This presentation will discuss the value of working through those challenges with SEND as a central focus because it will allow the development of predictive modeling and serve as a database for historical control and virtual control data. We believe that this will help to provide a better future for drug development.
