Integrating Data Management with Clinical Operations and Biostatistics to produce high quality data
Treating all Clinical Research functions as a single, seamless process means that Data Management must be the fulcrum around which all clinical trial processes revolve. To enable intelligent trial management, it is essential for Quality Assurance programs to adopt a proactive approach and build in risk mitigation measures at every step.
Using the Plan-Do-Check-Act cycle for effective planning ensures all-round higher efficiency; ultimately benefiting all stakeholders through the conduct of a cost-effective trial with greater chances of a successful outcome.
The Role of Quality Management in Clinical Trial Operations
This video explains various Quality concepts and discusses the benefits of implementing a holistic Quality Program in clinical trial operations. Looking at Site Operations, Data Management and Biostatistics from the perspective of one seamless process, rather than as isolated activities with different goals, makes for quicker timelines, reduced costs and all-round greater productivity.
Need for EDC in CDM
The entire Clinical Trials industry seems to be moving towards Electronic Data Capture. This puts pressure on every sponsor to move to the EDC platform to keep up with changing trends. This video stresses the need to accurately and adequately evaluate all combinations of factors to ensure the transition is successful, with as few teething problems as possible. Perhaps a hybrid system is a good way to kick-start the venture? A combination of sites using the paper-based approach and sites using Electronic Data Capture may give a pharmaceutical company the breathing space to plan for training and capital required to take on a full-fledged EDC venture. Another critical element: With the heavy investment required for EDC, it is important to choose a software that will deliver regulatory compliance as well as on-time, high quality results; and then stick with it.