Data management in clinical research. What is it all about?
Clinical Data Management is very critical in clinical research. The Data Management Department team works with a range of digital solutions and is actively involved in all stages of clinical trials from start to finish. For example, the CDM (Clinical Data Management) staff should thoroughly understand the main intention of the protocol, the primary and secondary objectives, “End points” and the study’s design. After all, the outcome of this very process is lean, high-quality and reliable data for trials.
Data managers help to achieve drastically reduced project timelines, from drug development to marketing authorization. Moreover, regulatory authorities also have an increased demand for specific quality systems to deal with data appropriately and obtain high quality data analysis. To date, it has been crucial for CDM to meet all industry standards and stay ahead by means of faster commercialization strategies.
Among the key CDM-related activities there are: data-entry, CRF (Case Report Form) designing, CRF annotation, data validation, database locking and database designing, which should be designed in accordance with the Case Report Form and replicate all its data points. The main goal of all these procedures is to provide statistically sound data with the minimum number of errors and missing values. To achieve that there are various software solutions, which, combined with best practices, help to essentially improve and increase data quality.
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