The clinical trial is a crucial step in drug development, which involves a long-term process and thus produces a huge amount of scientific data. These data will eventually make a new useful and marketable product in the therapy of the disease.
Is your brand generating tailored clinical experiences? The clinical data management process concerns a sequence of activities that include the development of a data management plan followed by the study configuration (design of the CRF, the configuration of the database, etc.). and training.
CDM is a current process and begins with the development of the protocol and ends at the end of statistical analysis.
This involves the collection, registration, processing, analysis, and reporting; monitoring data quality and data security; maintain the audit process; database closure; Storage of data while guaranteeing security and confidentiality throughout the process.
The main objective of data management is to provide high-quality data by minimizing the possibilities of errors or omissions of data.
To fulfill this objective, possible best practices are adopted to ensure that the data processed or that are about to be processed are complete, reliable, and properly analyzed.
Thus, the development of a data management plan (DMP) is the first step in the early configuration of the study. The DMP must define all components of the data management process.
Each component must specify the work to be done and the personnel responsible for the work. It should ensure that the Guidelines / SOPs are followed by the regulatory framework. The DMP remains directly throughout the lifecycle of a clinical study, in order to meet all updates/modifications made during the conduct of the study.