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Clinical IT Products
Cmed Technology Releases Timaeus 5 On-Demand eClinical Platform Cmed Technology
Pegasystems Releases Customer Process Manager For Life Sciences
Medidata announces Insights, the latest version of its clinical business analytics solution
Medidata announces streamline enterprise coding solution
BioClinica Releases Onpoint CTMS to Meet Growing Market Demand
ClearTrial releases v4.2 with API
Cmed announces forthcoming Timaeus Guided Trial Builder product
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BIOTECHNOLOGY COMPANIES IN THE NEWS
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BIOPHARMA COMPANIES IN THE NEWS
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CLINICAL NEWS & ANALYSIS
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Remedies for Safer Drugs
Explore Bio-IT World (Jan 21 2012) Regulatory Issues & Drug Safety
Pharmacovigilance experts have an abundance of signal detection tools to sift through large quantities of data seeking causal relationships between adverse events (AEs) and experimental drugs. They also have an assortment of data mining tools capable of finding statistical associations suggestive of problems regarding approved drugs. All this technology is intended to safeguard clinical trial participants, patients, and the reputation of recall-weary drug developers. But drug safety specialists can’t be sure which technology or signal detection method is best. (Read Full Article)
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19 Clinical Trials Aren't Enough
Explore Fool.com (Jan 20 2012) Electronic Data Capture (EDC) , Trial Design and Logistics
The FDA rejects Bristol-Myers and AstraZeneca's dapagliflozin. (Read Full Article)
Comment Mentions: FDA AstraZeneca The Food and Drug Administration
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Medidata: Integrating Infrastructure for Clinical Trials
Explore Bio-IT World (Jan 18 2012) Electronic Data Capture (EDC) , Regulatory Issues & Drug Safety , Trial Design and Logistics
Bio-IT World | Glen de Vries thought he would be teaching biology or chemistry in college, but somewhere en route to a satisfying career in academic research, he got distracted. Bio•IT World chief editor Kevin Davies spoke to de Vries about the progress of Medidata and the state of e-clinical technology in general. (Read Full Article)
Comment Mentions: SAP Kevin Davies, Ph.D. Medidata
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Biodesix Receives New EU and US Patents for Blood-based Oncology Tests
Explore businesswire.com (Jan 9 2012) Market Insights
Biodesix has announced the issuance of three additional patents which provide intellectual property protection for head and neck tests, lung cancer patient selection, and monitoring. (Read Full Article)
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FDA Has (Some) Social Media Advice For Pharma
Explore WSJ Blogs (Jan 9 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
Last month, the FDA released draft guidance on "responding to unsolicited requests for off-label information about prescription drugs and medical devices." (Read Full Article)
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ELSEWHERE IN THE PRESS
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Knome’s New CEO Signals New Directions in Genome Interpretation
Explore Bio-IT World (Jan 9 2012) Trial Design and Logistics
Bio-IT World | Knome, the first company to offer direct-to-consumer genome analysis, has appointed neurologist and biotech executive Martin Tolar as its new CEO as it seeks to push further into two prime markets for genome interpretation software -- biopharma and clinical genomics. (Read Full Article)Comment Mentions: Harvard Medical School Pfizer Inc Beckman Coulter
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FDA Releases Social Media Guidelines
Explore Bio-IT World (Jan 9 2012) Regulatory Issues & Drug Safety
News Brief | The Food and Drug Administration has released its guidelines for how pharma companies use social media to respond to questions about off-label use of drugs and devices. But they're still not as comprehensive as many hoped for. (Read Full Article)Comment Mentions: FDA The Food and Drug Administration
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Bristol-Myers buying Inhibitex for $2.5 billion
Explore MarketWatch (Jan 8 2012) Trial Design and Logistics
Bristol-Myers Squibb purchasing Inhibitex, a specialist in hepatitis C treatments, for $2.5 billion (Read Full Article)Comment Mentions: Bristol-Myers Squibb Bristol-Myers
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Quintiles consolidates patient communities into new Digital Patient unit
Explore pmlive.com (Jan 6 2012) Trial Design and Logistics
Contract research organisation Quintiles has combined its digital patient resources, including two online patient communities, into a single unit. The company’s new Digital Patient unit will bring together MediGuard.org and ClinicalResearch.com to offer its pharma clients a more efficient patient recruitment service. (Read Full Article)Comment Mentions: Microsoft Corp Google Inc Quintiles
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Lilly projects sharp drop in 2012 profit
Explore reuters.com (Jan 5 2012) Trial Design and Logistics
(Reuters) - Eli Lilly & Co forecast a sharp plunge in profits for 2012, the first full year its top-selling Zyprexa schizophrenia treatment faces generic competition, and its shares fell as much as 3.6 percent. (Read Full Article)Comment Mentions: Thomson Reuters Pfizer Inc Eli Lilly and Company
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ELSEWHERE IN THE PRESS
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Expect Measurable ROI of Innovation in 2012
Explore Bio-IT World (Jan 5 2012) Trial Design and Logistics
In 2011, biopharma sponsors continued to rely on an increasing number of contract research organizations (CROs) and eClinical technology solutions to support the research of drugs and related devices. Biopharma sponsors’ most precious asset: controlled access to clinical data throughout the course of trials, became more crucial and challenging than ever. Setting the stage for 2012, CROs are now not only responsible for executing studies and helping analyze and evaluate clinical data, but also offering access to data from all trials in one location. (Read Full Article) -
Flurry Of Cancer Pacts
Explore Chemical & Engineering News (Jan 3 2012) Market Insights
The year 2011 ended with multiple acquisitions and research partnerships through which the drug majors Takeda Pharmaceutical, Merck & Co., Eli Lilly & Co., and AstraZeneca gain access to compounds that biotech firms are developing for the treatment of cancer. (Read Full Article)Comment Mentions: AstraZeneca Merck & Co. Eli Lilly & Co.
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New year, new science
Explore Nature Publishing Group (Jan 2 2012) Trial Design and Logistics
Comment Mentions: US National Institutes of Health FDA NASA
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Perceptive Informatics DataLabs EDC Solution Implemented by 15 of the top Global Biopharmaceutical Companies
Explore Industry (Dec 30 2011) Electronic Data Capture (EDC)
News Brief | This latest milestone was preceded by an independent report from Industry Standard Research, which ranked the DataLabs EDC solution the highest in overall satisfaction among EDC solutions in a survey of principal investigators and site coordinators. (Read Full Article)Comment Mentions: Parexel International Perceptive Informatics PAREXEL International PAREXEL International Corporation
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The Perfect Pair: Drugs and Companion Diagnostics
Explore Bio-IT World (Dec 29 2011) Regulatory Issues & Drug Safety
New York Times | More and more often, the FDA is requiring personalized drugs to have companion diagnostic tests associated with them before approval. The trend has prompted some awkward partnerships in drug discovery. (Read Full Article) - See all articles >>
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Nature looks ahead to the key findings and events that may emerge in 2012.





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