Food and Drug Administration (FDA)
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CDC Threat Report: ‘We Will Soon Be In A Post-Antibiotic Era’
The U.S. Centers for Disease Control and Prevention has just published a first-of-its-kind assessment of the threat the country faces from antibiotic-resistant organisms, ranking them by the number of illnesses and deaths they cause each year and outlining urgent steps that need to be taken to roll back the trend. Read More »
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CDC Unable To Conduct Lab, Detection Work On Salmonella Outbreak
For all those Americans crossing fingers that no communicable disease, influenza or foodborne illness outbreaks would happen during the government shutdown, exactly that has occurred. Read More »
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CDISC and TransCelerate Announce New Standard for Breast Cancer to Support Data Sharing for Oncology Research
The need to rapidly and efficiently share new data in cancer research was recently, and powerfully, highlighted by U.S. Vice President Joe Biden as part of the Cancer Moonshot initiative. The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma, Inc. (“TransCelerate”) announce today the open availability of a new CDISC Therapeutic Area (TA) Standard for Breast Cancer. The CDISC global TA standards can streamline the way clinical research is conducted so that data can be readily shared among clinicians, researchers and regulators around the world, thus leading to more rapid and “smarter” research...
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CDISC Express Mentioned On Life Science Leader
CDISC Express, Clinovo's open source CDISC SDTM mapping tool, was mentioned on www.lifescienceleader.com. Life Science Reader is a must-read magazine and website for the life science and clinical trial industry. It features insightful articles to pharmaceutical, biopharmaceutical, and contract operations professionals. Read More »
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Chinese Melamine and American Vioxx: A Comparison
In contrasting China and America, pundits often cite our free and independent media as one of our greatest strengths, together with the tremendous importance which our society places upon individual American lives. Read More »
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Chinese Melamine and American Vioxx: A Comparison
In contrasting China and America, pundits often cite our free and independent media as one of our greatest strengths, together with the tremendous importance which our society places upon individual American lives. For us, a single wrongful death can sometimes provoke weeks of massive media coverage and galvanize the nation into corrective action, while life remains cheap in China, a far poorer land of over a billion people, ruled by a ruthless Communist Party eager to bury its mistakes. But an examination of two of the greatest public-health scandals of the last few years casts serious doubt on this widespread belief.
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Citing Anthrax And Smallpox Scares, White House Tells Federal Labs To Take Stock
After recent mishandling of potentially deadly pathogens, the White House is urging all federal laboratories to conduct what it is calling a “safety stand-down,” security and science officials announced Thursday. Agencies that handle infectious agents or toxins have been asked to complete overviews of their programs within 30 days of a memo dated Aug. 18...
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Clinical Decision Support Should Be Open Source
Clinical decision support is a long-standing occupant of the medical setting. It got in the door with electronic medical records, and has recently received a facelift under the term “evidence based medicine.”...
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Clinical Trial Design Management: Best Practices for Small Budget Studies
ClinCapture hosted the 12th BioTalks in Park City, UT, on the topic of Clinical Trial Design & Management: Best Practices for Small Budget Studies. This was the first event in the series hosted in the biotech hub of Salt Lake City. The panel discussion gathered experts from CROs and sponsor companies to conduct quality clinical trials in a cost effective manner. Industry experts shared their knowledge on running high quality, small budget clinical trials covering clinical operations to clinical data management and biostatistics...
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Clinical Trial Reporting Failures Can Harm Research, Patients
Hospitals, medical schools, businesses, and even the National Institutes of Health are routinely violating a federal law requiring clinical trials to be reported to the public, a STAT investigation recently found. In response, we asked experts to offer their thoughts on why low rates of clinical trial reporting is a problem, and what can be done about it...
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Clinovo Case Study: Open Source EDC Unmatched Cost-Efficiency
A worldwide leading technology medical device company was expanding the use of their number one medical device to new therapeutic areas...The sponsor was looking for a way to efficiently manage such large amounts of data while staying on time and on budget... Read More »
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Clinovo Launches New Version Of CDISC® Express, Its CDISC SDTM Mapping Tool
Downloaded Over 900 Times Globally, Clinovo Releases CDISC Express version 1.1, its SAS-based CDISC SDTM Conversion Tool, adding additional domains and following the new SDTM 3.1.3 specifications. Read More »
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Clinovo Speaks On Standards Implementation Strategies For Medical Devices At CDISC Interchange Europe 2014
President & CEO of Clinovo, Ale Gicqueau, was selected to present at the CDISC Interchange Europe 2014. The internationally renowned conference held in Paris, France on the 7-11th April 2014, is the premier venue for clinical trial experts dedicated to implementing and spreading the use of FDA-recommended CDISC standards.
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Clinovo Sponsors Outsourcing In Clinical Trials Southern California Conference 2013, In La Jolla (CA), September 24-25
Clinovo Will Release the Latest Version of its Open Source Electronic Data Capture (EDC) System ClinCapture and Present its Latest eClinical innovations at Booth #20 at Outsourcing in Clinical Trials Southern California. Read More »
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Clinovo White Papers Published In Summer 2014 Editions Of Leading Medical Device & Pharmaceutical Publications
White papers by Clinovo on CDISC Standards for medical devices and cloud-based eClinical technologies have been published in the latest editions of leading pharmaceutical publications Data Basics and Med Device Online...
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