Clinical Data Management (CDM) is a critical phase in clinical research. The quality of data generated plays an important role in the outcome of the study. Best practices are adopted to ensure that data are complete, reliable, and processed correctly. In regulatory submission studies, maintaining an audit trail of data management activities is of paramount importance. This has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. Many software tools are available for data management to ensure accuracy, reliability, and consistency of data with the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
SunBio IT Solutions is dedicated in developing tools to ensure electronic record compliance and track the retrieved CRFs and maintain their record to assure that the data is not lost and prevent misuse of the data. These electronic records comply with a Code of Federal Regulations (CFR), 21 CFR Part 11.