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The Next Episode: Extending the eTMF: Electronic Investigator Site File – written by Betsy Fallen, Consultant, eInvestigator Site File Project


Progress! The advancement of the eISF and its capabilities continues! As I see it, there are three significant opportunities in this platform. One key value is enhancing inspection readiness. If the full complement of expected Site Essential Documents is identified in the repository (like PhlexEisf), there is an opportunity to run reports to identify the missing or erroneous artifacts. Prompt identification and corrective action along the course of the trial instead of timed intervals or end-of-study can result in an inspection ready investigator eISF at any time.
Managing resources (typically with less) is on everyone’s objectives these days. Using technology to execute what has historically been a manual process will allow Sponsor and Site increased resource efficiency. Resources can be applied to scientific and interpretive management of the trial instead of administrative tasks. Applying reports and queries can lessen the 100% review of the documents and can be expected to reduce the cycle time to milestones such as Site Ready and Site Close Out.
To wrap inspection readiness and resource management together is the enablement of Document Risk Based Monitoring (DRBM). Similar to RBM of patient data, this is the process of identifying selected scenarios occurring across the eISF that must be addressed. Metadata assigned to each artifact and by the system will be able to be included in reports that can identify situations inconsistent with agreed-upon cycle times or compliance. Thresholds of risk tolerance from 0 to 100% can be set based on the situation.
My next update will share more details on these value-added opportunities for the PhlexEisf. Be sure to check back and follow me on my blog or on Twitter @BetsyFallen.

What our customers say about us...

"There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal."
Senior Director in Clinical Operations, top 20 global pharma
"Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them."
Associate Director of MRP Management, US pharma

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