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It’s About Time For Clinical Research Sites To Face Up To The Need For Part 11 Compliance
Clinical Informatics News | It’s About Time | Clinical research sites must recognize that certain electronic systems used in clinical investigations are subject to FDA Part 11 and require validation to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Aug 21, 2018
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This Drug Is Safe And Effective. Wait. Compared With What?
The New York Times | Comparative effectiveness research may be the best way to answer questions that patients and physicians face every day.
Aug 20, 2018
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DataCelerate Harmonizes Data, Unifies Companies During Drug Development
Clinical Informatics News | TransCelerate and its subsidiary BioCelerate have announced a new technology platform, DataCelerate, which will allow multiple de-identified research and development data types to be submitted, uploaded, converted, harmonized, and downloaded through an access controlled, secured environment.
Aug 16, 2018
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Tufts Launches National Trial Of Sequencing For Neonatal Diagnosis
Clinical Informatics News Brief | Tufts Medical Center has announced a national clinical trial--“Precision Medicine in the Diagnosis of Genetic Disorders in Neonates”--to study the integration of targeted genomic sequencing into neonatal diagnosis and care. The five-year, $8 million grant is from the National Center For Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).
Aug 15, 2018
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Launching A National Strategy For Alzheimer’s Clinical Research
Clinical Informatics News | An aggressive effort to increase recruitment and participation in Alzheimer’s Disease (AD) clinical trials is underway to attract more volunteers, complete more trials, keep pace with current research demands, and ultimately find promising new therapies.
Aug 14, 2018
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Experts Highlight Ebola Vaccine Progress, Suggest Next Steps
National Institutes of Health (NIH) | Important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine.
Aug 13, 2018
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New Mass. Law Aims To Improve Alzheimer’s Care
The Boston Globe | Half of people with Alzheimer's haven't been diagnosed, and half those with a diagnosis don't know. This landmark law aims to change that.
Aug 13, 2018
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ObvioHealth Announces Mobile Application To Transform Clinical Studies
Clinical Informatics News Brief | ObvioHealth announced the launch of its mobile application for site-less clinical studies—ClaimIt, which removes barriers currently troubling the clinical research industry by improving convenience for study subjects, enhancing compliance, lowering drop-out rates, and accelerating data capture.
Aug 8, 2018
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Once Its Greatest Foes, Doctors Are Embracing Single-Payer
Kaiser Health News | Young physicians are pushing the medical establishment to rethink its long-held opposition. The political fallout could be substantial.
Aug 7, 2018
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Precision Communication For Precision Medicine: How NIH’s All Of Us Is Tackling Patient Recruitment
Clinical Informatics News | In May, the National Institutes of Health launched national open enrollment for their All of Us Research Program. Now, the precision medicine is looking to make a difference in their approach to outreach.
Aug 2, 2018
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Veeva Systems, The Pistoia Alliance, CRF Health, And More: News From July 2018
Clinical Informatics News | July was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Veeva Systems, the Pistoia Alliance, CRF Health, and more.
Jul 30, 2018
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Optimizing Patient Recruitment For Effective Site Start Up
Clinical Informatics News Contributed Commentary | Since clinical trials are the backbone of therapeutic development, as well as the source of new hope for patients facing devastating diseases and the HCPs who treat them, shouldn’t it be easy—in theory—to find willing and appropriate patient participants? As evidenced by the statistics – and experience – the answer is no.
Jul 26, 2018
