Industry News

What Is Taking So Long For Meaningful Interoperability In Clinical Research?


From Clinical Leader comes a very timely article on the state of interoperability within clinical research Clinical Trials today can benefit tremendously as a result of the value produced from integration with EMR systems, leveraging Real World Data and Real World Evidence, and the adoption of eSource! Continue Reading The Entire Article

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WideTrial Partners With Oncotelic to Bring Expanded Access Platform to Cancer


WideTrial , one of TrialStat’s strategic partners has partnered with Oncotelic to bring the Expanded Access Platform to Cancer. June 03, 2019 (ACCESSWIRE via COMTEX) — SAN FRANCISCO, CA / ACCESSWIRE / June 3, 2019 / WideTrial Inc., a third-party sponsor of Expanded Access programs, has begun a partnership with Oncotelic Inc., a wholly owned subsidiary…

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FDA to Launch Expanded Access Pilot ‘Project Facilitate’


The goal of Project Facilitate is to make it easier for oncologists or healthcare providers without the regulatory experience or resources to navigate the single patient IND process. “Access to clinical trials and access to novel therapeutics for patients is still a problem. We know that not all oncologists or healthcare providers have the regulatory…

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward


In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…

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The Proposed New FDA Rule Brings Changes To Informed Consent for Clinical Studies


The Diagnostic and Interventional Cardiology website posted an important article about recent proposed changes by the FDA which may allow Institutional Review Boards (IRB) to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants. The conditions under which an IRB could do this are limited and detailed in the…

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FDA to revamp medtech cybersecurity — with your help


The FDA has announced it is taking additioanl steps to improve the security of Medical Devices. The agency will soon release a new draft of premarket guidance document with recommendations to combat growing security threats. “In addition, the agency announced multiple partnerships with manufacturers, hospitals and more — as well as the release of a…

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Efficiency, Transparency and Standardization: The Roadmap for Improved Data Collection in Medical Device Clinical Trials


MassDevice has written an excellent article outlining the benefits Medical Device Trials receive when using a Unified eClinical Suite. “Implementing a unified data platform for medical device trials can yield significant improvements in efficiency, transparency, and standardization, providing resource- and budget-strapped trial teams with accessible, more accurate data for faster, more informed decisions.” Read The…

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Cancer Immunotherapy Wins the 2018 Medicine Nobel Prize


James P. Allison of MD Anderson Cancer Center in Houston and Tasuku Honjo of Kyoto University in Japan have won the Nobel Prize in physiology or medicine for advances in harnessing the immune system to fight cancer. Read The Entire Article Here.

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Cancer Drug And Antidepressants Provide Clues For Treating Brain-eating Amoeba Infections


“Researchers have now identified three new molecular drug targets in Naegleria fowleri and a number of drugs that are able to inhibit the amoeba’s growth in a laboratory dish. Several of these drugs are already approved by the US Food and Drug Administration for other uses, such as antifungal agents, the breast cancer drug tamoxifen…

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A Mere Drop of Blood Makes Skin Cells Line Up


“What happens to skin cells when they are confronted with blood? A team of researchers from Oslo University Hospital, led by Emma Lång and Stig Ove Bøe, performed experiments on blood-deprived cells that were subsequently exposed to blood serum. Remarkably, all the cells started to move and grow in the same direction as soon as…

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