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Budget Woes Stall Clinical Trials and Stymie Sites
Explore Bio-IT World (Feb 20 2012) Trial Design and Logistics
Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line. According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate budgets and contracts for clinical trials.
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Why Bristol-Myers Squibb Could Break Out This Year
Explore The Motley Fool (Feb 15 2012) Electronic Data Capture (EDC) , Trial Design and Logistics
Why Bristol-Myers Squibb Could Break Out This Year
Comment Mentions: FDA Merck & Co Inc Bristol-Myers Squibb
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How to Successfully Repurpose a Drug
Explore WSJ Blogs (Feb 14 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
As today’s WSJ reports, there is growing interest in running clinical trials that repurpose drugs that have already won FDA approval for another disease.
Comment Mentions: FDA National Institutes of Health NIH
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FDA unveils biosimilars guidance
Explore Nature Publishing Group (Feb 9 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
Move could open the door to cheaper generic versions of biological drugs.
Comment Mentions: FDA European Medicines Agency
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Craig Lipset on the Recruitment Mind Shift
Explore Applied Clinical Trials (Feb 9 2012) Trial Design and Logistics
REMOTE is the first-ever randomized clinical trial under an investigational new drug (IND) application in which the study is managed entirely using electronic tools and allows subjects to participate in the clinical trial regardless of their proximity to clinical sites. Pfizer’s pilot project uses mobile phone and Web-based technology to collect necessary data for the trial, without clinic visits. The trial was announced last June. And this month ACT, Editor-in-Chief Lisa Henderson talked t
Comment Mentions: Pfizer Inc
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Picture Perfect: Imaging in Drug Discovery and Translational Medicine
Explore Bio-IT World (Feb 7 2012) Market Insights , Trial Design and Logistics
Bio-IT World | Imaging in drug discovery has been rising to the forefront of conversations more and more recently. Managing editor Allison Proffitt spoke with Ken Kilgore, Director of Immunology Pharmacology at Janssen Research & Development (formerly Centocor Research & Development), a Johnson & Johnson company, about how—and why—imaging’s role is changing in drug discovery.
Comment Mentions: Novartis International AG Pfizer Inc Johnson & Johnson
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Dana-Farber lands $10M for cancer research
Explore Business News (Feb 1 2012) Trial Design and Logistics
Dana-Farber Cancer Institute has been awarded a $10 million grant rom the Massachusetts Life Sciences Center to support the expansion of its cancer imaging research program, Mass High Tech reports. Funding for the grant comes from the state’s 10-year, $1 billion Life Sciences Initiative. The money will support the establishment of Dana-Farber's Molecular Cancer Imaging Facility, a $20 million research initiative in South Boston to develop new molecular imaging probes. As MHT reports, the imaging facility will expand several of Dana-Farber’s basic and clinical research enterprisesfocused on developing targeted cancer therapies.
Comment Mentions: Dana-Farber Cancer Institute
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Bush Doctrine: The Pharmaceutical Safety Data Problem
Explore Bio-IT World (Jan 27 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
Bio-IT World | The Bush Doctrine: What the industry calls “safety data” covers everything from discovery-oriented in vitro or cell based studies to extensive GLP toxicology study data, voluminous clinical study records, and post-marketing/pharmacovigilance systems. It leads one to wonder: does anyone have informatics systems that allow safety investigators across the pharma enterprise to effectively mine this ocean of information?
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Researchers defend benefits of mutant flu research
Explore Nature Publishing Group (Jan 25 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
A dire lack of global virus surveillance doesn't negate the potential of mutation monitoring, argue two researchers behind the mutant flu research.
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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.
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.
Comment Mentions: SAP Kevin Davies, Ph.D. Medidata
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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."
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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.
Comment Mentions: Harvard Medical School Pfizer Inc Beckman Coulter
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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
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.
Comment Mentions: Microsoft Corp Google Inc Quintiles
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