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Moving Towards Electronic Trial Master Files





Streamlining Clinical
Research with Electronic
Trial Master Files
Sponsored by PharmaVigilant
In this episode, Mr. DeSanti discusses the clinical trials trend of moving to an Electronic Trial Master File platform. He covers the strategic and practical aspects of making the move, and what the payback is for doing so.
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About PharmaVigilant:
Based in Westborough, Mass., PharmaVigilant is a SaaS company founded in 2005 to provide broader technologies to streamline the clinical trial process for biopharmaceutical companies. Its full suite of patient-based technology automates the collection, management and analysis of clinical trial data and most importantly puts that data in the sponsors' hands when and how they want it. Sponsors rely on PharmaVigilant to ease the regulatory and FDA submission and approval process and ultimately go-to-market more quickly with top quality drugs.
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James DeSanti

James DeSanti

James DeSanti has more than 25 years of experience in the pharmaceutical and software industries. He started his career at Johnson & Johnson in sales and marketing, on the commercial side, and his training was in product launch and execution. DeSanti then moved on to hold influential senior management roles at Walsh Americas and Phase Forward, among others.
DeSanti's experiences on the pharma side proved advantageous as he developed a keen understanding of the budgetary and regulatory challenges that sponsors' face. In 2005, recognizing the need for a broader range of technologies to curb research costs and streamline the trial process from start to finish, he founded PharmaVigilant, and began the task of meeting pharma's crucial trial demands. He recognized the unrealized potential to replicate the efficiencies of EDC in other clinical trial processes' as a result, he introduced a suite of forward-facing products that produce actionable data for sponsors and provide a level of flexibility, access and control over clinical trial data that has not been seen in the market yet.

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