Highlights from Day 1 of the Medidata Symposium

posted on April 25th 2014 in News & Events with 0 Comments /


Day 1 of the Medidata Symposium was great! The keynote presentations and sessions were insightful. Below are a few highlights I’m taking away from the symposium:

Theme 1—Why settle?

  • “Challenge your technology providers,” Jason Carlson, Gilead Sciences

  • In the future there will be an increased use of analytics to provide a view across data sources and/or tools

  • RAVE Safety Gateway reduces duplication of data entry and reconciliation to allow faster reporting of AEs to authorities

  • Risk-based clinical data monitoring is effective and achievable, but only works if the data is aggregated

Theme 2—Redefining electronic data capture

  • The goal is faster, lower-risk, cost-effective clinical trials

  • “Next generation EDC will include bring your own device (BYOD) and wearables,” Glen de Vries, Medidata

  • Targeted SDV + RAVE = 30% reduced SDV coverage

  • Targeted SDV + RAVE results in fewer onsite monitoring days

  • Medidata Patient Cloud is a really simple ePRO that improves the clinical trial experience for patients

  • Go beyond capturing patient data to leverage clinical data for actionable information on trends and outliers

Theme 3—Exponential change on the horizon, and some key questions to answer

  • How does the BYOD impact clinical trials?

  • How is EDC redefined in the internet of things?

  • Can consumer devices be used to record assessments in clinical data?

  • Who owns the data in these devices?

Theme 4—Pay the sites

  • “For sites, cash flow is the biggest problem. Sites wait 6 months for payment. Truly unsustainable,” Christine Pierre, Society for Clinical Research Sites (SCRS)

  • In a study by SCRS, 51% of sites indicate they pay more attention to studies that pay monthly

  • “Opportunity for sponsors to help sites use the data in their EMR for feasibility assessments,” Christine Pierre, SCRS

It has been fun to catch up with old friends and meet new ones too. The Medidata Symposium continues today. If you are attending, please stop by the Innovation Lounge this afternoon beginning at 1:30 pm PT and see us at the eClinical Solutions booth. If you aren’t attending, but want to keep up on the updates, follow the action on Twitter at #MedidataSym.

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