The demands made by the pharmaceutical business as well as the regulatory authorities led to the development of the field of clinical data management, sometimes known as CDM. As the push to “fast-track” the development of pharmaceutical products continues to gain momentum, regulatory authorities have responded by mandating that quality-assurance requirements be followed while gathering the data that will be utilised in the process of evaluating potential new drugs.

The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization are two examples of such standards that are particularly important to the Clinical Data Model (CDM). Both of these standards were developed by the Clinical Data Interchange Standards Consortium (CDISC) (CDASH). The use of the former is currently required by law in the United States. FDA stands for the Food and Drug Administration (FDA). The latter developed a standardised format for collecting data across research, which makes it easier to manage and assess data submission

In clinical data management (CDM), specialised software tools are used to build audit trails, which allow for the reduction of differences even in the most extensive and difficult clinical studies.