Global News

FDA to modernize digital health software regulatory framework

Tuesday, October 10, 2017

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S. The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily the product.”

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There’s a lot of ways to leave a good impression

Tuesday, October 10, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

There is no better learning opportunity than to observe an experienced individual correctly complete a process that you are trying to understand/implement outside of a classroom in a real-world environment. It lends depth to the sometimes-lifeless instruction of written curriculum. The demonstration tames the daunting unknown, creating confidence in an ability where there may have been none. It shows diversity of technique and timing, and expands that which is preconceived about an untried task.

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CTTI takes on site investigator turnover in new recommendations

Friday, October 6, 2017

The Clinical Trials Transformation Initiative (CTTI) unveiled new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.

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Research!America announces 2018 Advocacy Awards Honorees

Friday, October 6, 2017

A former congressional leader who was instrumental in doubling the NIH budget, the head of a global research center aimed at reducing the burden of disease, two long-time mental health advocates dedicated to accelerating research, a rare disease organization committed to biotech innovation, and a world-renowned vaccine researcher are among those who will be honored at Research!America’s 22nd annual Advocacy Awards on Wednesday, March 14, 2018, in Washington, D.C. The honorees for the Isadore Rosenfeld Award for Impact on Public Opinion and the Edwin C. Whitehead Award for Medical Research Advocacy will be announced in the coming weeks.

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SynteractHCR moves headquarters to Carlsbad, California

Friday, October 6, 2017

SynteractHCR, a full-service global CRO, has recently moved to its expansive new facility in Carlsbad, California. The approximately 38,000 square feet of space at 5909 Sea Otter Place has been designed with an open concept to foster collaboration and creates a dynamic team environment, right in line with the company’s innovative business philosophy. Headquartered in San Diego County, with additional offices in the Research Triangle Park (RTP) area of North Carolina as well as 10 additional offices in Western, Central, and Eastern Europe, SynteractHCR sits in six of the top 10 biotech centers in the world and supports clients in conducting clinical trials worldwide.

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