Clinical data management is involved in all aspects of processing clinical data, collection of data, cleaning and management of subject trial data. CDM ensures that the clinical data is sufficiently clean to support statistical analyses and its interpretation.
Clinical data management is the process in which the demanding data should be collected from its source data and it should be accurate, credible, error free and statically sound. CDM ensure that the data Should be attributable, legible, contemporaneous, original, and complete data collected from the operation.
BizNET-CTM provides a platform which facilitates the process of data collation, evaluation, transmission and review. It emphasizes to the accuracy, integrity, transparency and accountability of the clinical data being produced.
BizNET-CTM allows end to end solution from designing of study related documents to its subject specific data collection, review and analyses and finally to best suit the statistical and integration part for final documentation. The data generated is precise, reliable and easily reproducible that increases sponsors’ confidence in the process, data and ultimately the product itself that is regulatory compliant.
It also allows data discrepancy generation and resolution, Edit Checks generation and execution, AE/SAE reconciliation, medical coding using standardized dictionaries available for coding AE. Also allows version control in case of any amendment(s) in the study eCRF and lock data in eCRF.