Blogs Case Studies White Papers

Prevention and Remediation: The Completeness Crisis

With increasing frequency, TMF stakeholders face a completeness crisis at TMF close-out.  Delays in TMF closure increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Sponsors, when asked about the growing trend of TMF incompleteness, are likely to cite a challenging relationship with a CRO. Regulators, however, have little sympathy for this … Read more

Understanding the Humans of the TMF

Evaluating TMF stakeholder attitudes to achieve inspection readiness Any solution to the problem of TMF inspection readiness must consider more than just the hardware and software of the eTMF, but must also consider how electronic tools augment the human roles, processes, and relationships that author the narrative within each TMF. This whitepaper, utilizing original survey … Read more

The Four P’s of Migration

Change isn’t easy. Although your current TMF system may no longer align with your team’s goals, the prospect of migrating to a new eTMF system can be intimidating. Selecting the correct eTMF system for your team’s needs is only an initial step. Deployment of a new eTMF system requires training, updated processes and SOPs, complete … Read more

Your Worry Free Migration to eTMF

In a recent blog post, Sholeh Ehdaivand, President and CEO of LMK Clinical Research Consulting, discussed the benefits of migrating from paper or hybrid TMF to eTMF. In her blog post, Sholeh wrote at length about the potential of a “shiny, new eTMF system”. Simply put, the transformative potential of the eTMF is astounding.  Beyond … Read more

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