Discover Our New CTMS
Monday, October 29, 2018 | 2:55 PM
It was great to hear key Clinical Operations leaders describe how they get their teams to row in the same direction, unifying best practices and creating business processes that make for efficient teams and impact how the industry approaches trial master files.
This year, two specifically hot topics were systems integration and inspection readiness. How are they related?
eTMF is an ever-growing and exciting movement; however, many potential users still require convincing of the value and as an essential component to save time and money and reduce risks. The TMF does not just include final documents, though. It contains significant versions of each essential document, providing a full picture of the study. The value becomes much clearer when the larger content management picture is taken into consideration. Fully integrated document management capabilities are key to author, edit, and approve documents and make it much easier to provide the complete picture to inspectors. Users are smart to be wary of completely standalone technologies to understand the value in an integrated approach to their content management needs across the lifecycle of a study.
Many reported TMF inspection findings could be avoided by defining an integrated workflow and using a single platform across studies and the organization: One great thing about inspection requirements is the “freedom” to design your SOPs. This gives sponsors some control over their processes, but inspectors will expect results! This means that your e-clinical infrastructure has to align with your resources and SOPs, as well as regulations, among other considerations. Choosing a comprehensive system that can be configured to all of these variables is essential.
Some common critical findings during inspections have included:
You can learn more about the findings and how to avoid them in our recent white paper.
The right approach to technology is just a means to execute, though. People are key to successfully embodying best practices within the organization and committing to processes that will ultimately create efficiency and control risk. A healthy collaboration between stakeholders, daily business users, and external third parties (vendor/technology partners, CROs, etc.) is crucial.