Simplifying the Regulatory Submission Process with a Modern CTMS
Converging technologies in the clinical trials space are improving efficiencies on most fronts of the clinical research process. Gaps remain, however, and if we as an industry are to drive further efficiencies in clinical development, we must rethink our processes and our technology in a more modern context. Through direct work with a focus group composed of representatives from many divisions of the industry, the product development team at DATATRAK reached the conclusion that regulatory submission, among other operations of interest, remained largely unassisted by the current ecosystem of clinical technology. Working in collaboration with industry representatives, this group explored the value that pulling the regulatory submission process into a modern Clinical Trial Management System (CTMS) could have, and devised a purpose-built solution to address that need. This chapter seeks to discuss the ways in which collaboration with industry professionals resulted in a CTMS platform that drives efficiency and value in the regulatory submissions through:
Reusability – The elimination of redundancy: Modern technologies that are purpose-built should seek to identify the constituent parts of the workflows they support with the intent to provide reusability. By identifying the most common elements in a process and modularizing them, the most common steps, particularly in the clinical trials space, can often be eliminated. The elimination of redundancy is among the simplest ways to drive efficiency with technology.
Reduction of human error: A platform designed to support the enterprise should also inherently reduce user error and the associated risk. By bringing one’s processes into a technological system that is specifically designed to support them, the tasks and procedures involved should necessarily become more intuitive and easy to complete. By pulling human processes into a more human-friendly environment the chance of mistakes made due to complexity decline. Additionally, once the decision has been made to bring these user-executed tasks into a platform, the software can then be employed to check and correct user errors as they happen. By getting out ahead of the problem, the potential for downstream impact of human error can be substantially reduced.
Making new workflows available: A modern software solution should not simply improve your existing workflows; it should also make new workflows available. The onboarding process should be simple, quick, and designed with your current processes in mind. The solution should allow users to perform their usual tasks more efficiently while at the same time offering new ways to complete them.
Delivering actionable data: Ultimately a platform like a CTMS should deliver more actionable data in all things. The simple act of bringing a process into the technology should render the data it yields more usable than before, allowing it to be more quickly aggregated, analyzed, and acted upon. In the end, this is the greatest value driver for technology because it creates value where it previously did not exist.
The power of technology can be harnessed to simplify the regulatory submission process
Modern technology delivers actionable data to improve workflows, reduce human error, and provide greater trial team efficiency.
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