DFS Pharma is a Contract Research Organization (CRO) specializing in pharmaceutical data management and statistical support. They partner with like-minded domestic and international CROs to offer clients in the worlds of biopharmaceuticals, biotechnologies, and veterinary medicine a fluid sponsor-consultant experience. “The industry has changed quite a bit over the last 20 or so years,” Rod McGlashing, Senior Director of Operations for DFS Pharma, told me as he quickly returned a text to a client before I asked my first question. He apologized for the necessary delay as the distinct buzz of a phone turning to vibrate could be heard over my speaker. “It has moved from a strictly paper- based data collection model that required a great deal of transcriptions and, as a result, a great deal of transcription errors, to an Electronic Data Capture or EDC model, where clinical sites enter the clinical data directly into the data collection instrument or study database,” he continued. “The industry is now moving toward technologies that work to sync the bedside source data with the clinical database via mHealth or eSource, thereby eliminating the possibility of additional transcription error. That being said, the industry is slow to adapt. And for good reason, as the required regulations addressing the safety of patients is the utmost priority. These technological and related procedural changes are advancing hand-in-hand with industry standardization as it relates to the data and metadata, and international harmonization amongst the various regulatory bodies and industry leaders.” I quickly changed my approach to match Rod’s momentum which, I learned, is also the approach DFS Pharma takes every day with every client.
“The industry is now moving toward technologies that work to sync the bedside source data with the clinical database.”
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