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eTMF Adoption and Integration Accelerating

Halloran Consulting Group Founder, Laurie Halloran, and former principal consultant, Mark Vermette, were recently quoted in a feature in the December CenterWatch newsletter titled “eTMF Adoption and Integration Accelerating.” The article details the rise of electronic master file (eTMF) use as a significant technological advancement, solving the costly and inefficient problems TMFs have been causing in recent years.

According to Laurie Halloran:

“Some sponsors are unprepared for the amount of change they need to do to make sure it’s integrated. It’s not Facebook.”  

 “The little details are important, especially document naming, when you’re finalizing everything. People don’t understand what it’s like to retrieve 10 boxes of paper for a study done last year.” To make it more manageable, companies may set up eTMF for current studies first.

Mark Vermette noted that before eTMF can move forward, process problems must be approached.

“We’ve been paving a cow-path applying technology to old processes. For us to advance eTMF in five years, we need a discussion about process. These are healthcare providers, and what we’re asking is an imposition on their conversation with their customers, by asking them to do more extra work. We need to stop asking for double data entry. If their interface of choice is EHR, we need to do whatever it takes to extract that. You have to look at it from the patient/physician perspective.”

For CenterWatch subscribers, the full article can be read here.