CLINICAL DATA MANAGEMENT
What is Clinical Data Management?
management is the process of collecting, cleaning, and managing clinical data during
your clinical trial. The primary objective is to
provide high-quality data and gather the maximum amount of valuable data for
analysis. High-quality data should be attributable, legible, contemporaneous,
original and accurate (ALCOA). The obtained data set needs to be suitable and
statistically valid. The quality and type of data generated are important for the
outcome of the study.
systems and statistics
Manual and electronic data capturing systems (EDCs) are used and
regulatory compliant. Which to choose is part of your clinical strategy and
depends on your specific trial. An EDC provides investigators a tool to
directly upload the data in electronic case report forms (eCRFs). At the end of the clinical trial the data set in the system is provided to
statisticians for further analyses. An appropriate statistical analysis should
reveal differences in effects between two or more interventions and determine
whether such differences are significant or due to chance.
Qserve's clinical team has experienced
clinical data managers and works with a professional, validated electronic data
capture (EDC) system. Thereby we can ensure the reliability of your study data
and construct a compliant database for final analysis. Our team can assist with
all, or part of the data management process, for example, the statistical
analysis. When clinical
data collection and statistical considerations are not suitable your study