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Side Effect Kills Cancer Patient In Stemline Therapeutics Drug Trial
TheStreet | Stemline's SL-401 has demonstrated robust overall tumor response rates in its clinical trial but the drug is also now tied to three patient deaths from capillary leak syndrome.
Feb 2, 2017
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New GCP R2 Guideline Emphasizes Risk Management Through People, Process, And Technology
Clinical Informatics News | A major update to the international guideline for clinical trials, from the International Conference on Harmonisation, emphasizes quality risk management, critical processes, and data identification.
Jan 31, 2017
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This Health App Gets Indians Connected With Medical Specialists In Just 30 Minutes
Forbes | Aiming to tackle the severe shortage of specialist doctors in India, the 27-year olds behind the DocsApp platform promise a consultation with a doctor within 30 minutes of logging on to their app (with a little AI help).
Jan 30, 2017
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Hospitals Scramble To Aid Overseas Patients After Trump Order
STAT | Two of the nation's leading medical centers have identified nearly two dozen overseas patients who could be affected by Trump's order.
Jan 30, 2017
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Welcome to Miami: New Products and Launches at SCOPE 2017
Clinical Informatics News | Several companies took advantage of the 8th annual Summit for Clinical Ops Executives to make new product and business announcements. Here are a few of the exciting things heard and seen on the show floor.
Jan 27, 2017
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Illumina, Medidata, Rho, And More: News From January 2017
Clinical Informatics News Brief | News, products, and partnerships from around the clinical trial and healthcare community including news from Illumina, Medidata, Rho, and more.
Jan 26, 2017
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2017 Clinical Informatics News Best Practices Awards Winners Announced
Clinical Informatics News | The winners of the Clinical Informatics News Best Practices Awards were announced on Wednesday at the Summit for Clinical Ops Executives, SCOPE, in Miami, Fla. Prizes were awarded to Mytrus, CluePoints, and DrugDev.
Jan 25, 2017
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Merck & Co. Opens Cambridge Exploratory Science Center, Plans To Hire 30 More Employees
BioSpace.com | The end of 2016 brought a new beginning with Merck's opening of its new Exploratory Science Center (ESC) in Cambridge, a cutting edge facility that will focus on early discovery research.
Jan 24, 2017
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FDA Launches Oncology Center For Excellence
Clinical Informatics News Briefs | Even as rumors and speculation swirl around the new head of FDA under President Trump, the U.S. Food and Drug Administration announced today that it is establishing the Oncology Center of Excellence and appointing Dr. Richard Pazdur as its director.
Jan 19, 2017
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New FDA Chief Should Have Medical Experience Drugmakers Say
Bloomberg.com | President-elect Donald Trump's pick to lead the U.S. Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications' effectiveness, drugmaker executives said in comments indicating opposition to two candidates for the regulator's top post.
Jan 18, 2017
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New Rule On Clinical Trial Reporting Doesn't Go Far Enough
STAT | A new rule requiring that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov doesn't go far enough to improve sharing trial information.
Jan 17, 2017
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Site-Less Clinical Trial Depends On Pharmacists' Relationships With Patients
Clinical Informatics News | Center Point Clinical Services, a contract research organization, launched what it calls “the world's first site-less, technology CRO,” designed to increase patient recruitment, engagement, and successful trial completions at lower cost.
Jan 17, 2017
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Using Real World Data to Enhance Clinical Trials
Clinical Informatics News Contributed Commentary | Randomized clinical trials remain the trusted standard for assessing pharmaceutical drug and medical device safety and efficacy. Real world data can provide important health information about patients in the social context of their day-to-day lives.
Jan 12, 2017