Reflection
Case Report
After
the presentation that was given from the consultants in the discussion board, I
would still recommend the Web-enabled EDC – Electronic Data Capture. The
paper-based process and digital imaging are short term fixes and would not benefit
P&G in the long run. The goal was to cut the time in half and EDC provides an
efficient service. D’Alonzo saw the
value during the six pilot trials and knew that EDC could reduce the amount of
time in half to complete clinical trials for prescription drugs.
Steve
(my manager), there was a CRF & CRA cost analysis slide in the presentation
that showed a significant cost savings. The
analysis had three different phases with a total paper savings and a total CRA
visit savings. In phase III, there was $714,000 in total paper savings and $3.2
million in total CRA visits with approximately 3,000 patients. It’s was
impressive to see a total savings of $5 million in the three phases.
Steve, as managers we must have proper
training to the sites and must provide employees with the resources so they can
learn and perform effectively and efficiently with EDC. I don’t want to be like
other pharmaceuticals companies that were slow to adopt EDC. There must be organized
training seminars and training classes for our employees. We must value
employees’ feedback and try to adjust to their needs when EDC is rolled out. For
example, we must find a solution for the edit checks if this is one of the biggest
challenges with EDC. I would like to take the lead on implementing EDC once
approved from the executives. I can add value and show that EDC can reduce
time, save a significant amount of money thus we can continue to be a major
driver within the P&G Healthcare division.
With today’s technology double
entry shouldn’t exist…Do you have time this week to discuss EDC?
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