What is Clinical Data Management?

Clinical data 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. 

EDC 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.

Expertise

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 might fail.  

Important factors in clinical data management where we can support you:

·         Design of the database and the case report form (CRF)

·         Data management plans: instructions, responsibilities,  data sources, quality control

·         Data validation based on validation checks

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