• New House Bill to Expose All Clinical Trials in Public Database

    Aug 6 | Mass Device | Four House Democrats aim to close loopholes in the U.S. government's clinical trial reporting requirements to ensure that all human studies are publicly disclosed online. The proposed Trial & Experimental Studies Transparency Act would require drug makers to report all studies and results publicly through the ClinicalTrials.gov website. 

     

    Aug 6, 2012

  • Sharp Dip in US Drug Approvals Forecast

    Jul 30 | Pharma Times | The US Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 than it did last year, as the industry faces a number of ongoing operational risks, according to a new report.

    Jul 30, 2012

  • Parexel Alliance for Drug Development in South Korea

    Boston.com | Parexel International has been chosen by the Korea Drug Development Fund to help Korean biopharmaceutical companies develop and commercialize health care products for the global market.  

    Jul 19, 2012

  • DIA 2012 – Faster, Smarter, Easier (Part I)

    eCliniqua | Correspondent Ann Neuer takes her annual pulse of e-clinical trends from the vendor community exhibiting at the Drug Information Association (DIA) conference. In part 1 of a 2-part series, she profiles a few companies that stood out for me, including Greenphire, Oracle, and a couple of start-ups in the Entrepreneur Pavilion.

    Jul 13, 2012

  • ERT acquires Pittsburgh-based Invivodata

    Pittsburgh Business Times | Invivodata Inc. has been acquired by technology company ERT, making the latter it says the number one provider of clinical outcome assessments.

    Jul 9, 2012

  • Voice Algorithms Spot Parkinson's disease

    BBC News | British mathematician Max Little has developed a cheap, non-invasive test to diagnose Parkinson's disease based on his discovery that symptoms can be detected by computer algorithms that analyse voice recordings. He is now recruiting 10,000 volunteers to have their voices recorded.

    Jul 5, 2012

  • How to Tell When A Drug Company Fibs About Clinical Trial Results

    The Street | Reporter Adam Feuerstein diligently dissects an upbeat official announcement from Osiris about its Prochymal heart attack study, parsing the language of clinical trial results while finding independent sources of truthful information, such as clinicaltrials.gov

    Jul 3, 2012

  • Medidata, Tufts Study Leads News Roundup from DIA 2012

    eCliniqua | Medidata Solutions, BBK Worldwide, ArisGlobal and iGate were among the e-clinical companies making news at the annual gathering of the Drug Information Association (DIA) in Philadelphia.

    Jul 3, 2012

  • Glaxo Agrees to Pay $3 Billion in Fraud Settlement

    Jul 3 | New York Times | In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline has agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug.

    Jul 3, 2012

  • DIA: Drug, Food Safety Trumps Jobs, says FDA's Hamburg

    Philly.com | Despite the global economic turmoil that has affected the drug industry, regulatory leaders from North America and Europe, including FDA commissioner Margaret Hamburg, opened the 2012 DIA convention saying that safety and science must not be compromised for the sake of jobs that might be created if rules were relaxed.  

    Jun 29, 2012

  • COMMENT: 2012 Survey Demonstrates Growth in eTMF and Impact of Standards

    eCliniqua COMMENT | In a Guest Commentary, Maryanne Quinn and Fran Ross discuss the results of a new survey that indicates a significant growth in the number of organizations transitioning to electronic Trial Master Files (eTMF).   

    Jun 28, 2012

  • Roundtable on Translational Cancer Research Trends

    June 18, 2012 | Bio-IT World | One of the highlights of the 10th anniversary Bio-IT World Conference last April was a plenary roundtable on translational cancer research, featuring four outstanding cancer researchers: computational biologist John Quackenbush (Dana-Farber Cancer Institute); drug discoverer Julian Adams (Infinity Pharmaceuticals); clinical researcher Jose Baselga (Mass General Hospital, Boston); and geneticist Sir John Burn, (Institute of Genetic Medicine, Newcastle University, UK/QuantuMDx).

    Jun 18, 2012

  • Clinical Trial Registries Step Up Reporting Requirements

    June 18, 2012 | eCliniqua | Clinical trial registries will be upping the ante by requiring more disclosure from biopharmaceutical companies, but it’s not yet clear what additional information will be required or when compliance will be expected. The next round of disclosures will expand the level of transparency in widely used databases such as ClinicalTrials.gov and EudraCT due to legislation requiring industry, academia, and government to be more forthcoming with clinical trial specifics.

    Jun 18, 2012

  • Foundation Medicine, Novartis Partner for Clinical Trial Enrollment

    Jun 11 | News Brief | Foundation Medicine and Novartis are partnering on cancer drug testing. Novartis plans to use Foundation's technology as part of its cancer trial enrollment process over the next three years, focusing on Phase 1 and 2 oncology clinical programs. 

    Jun 10, 2012

  • Clinical Ink Named Cool Vendor for EDC System

    Jun 11 | Gartner | Clinical Ink has been named a Gartner Cool Vendor for 2012 with analysts saying that the technology has "significant disruptive potential in the area of EDC systems." Clinical Ink's technology began development in 2009. 

    Jun 10, 2012

  • Agility Clinical CRO to Work With Small Drug and Device Companies, Pediatric Focus

    May 31 | News Brief | New specialty CRO Agility Clinical, Inc., was announced yesterday. Agility will focus on providing customized clinical research and consulting services to small and virtual biotechnology, specialty pharma, medical device and diagnostic companies. The company says it has a "special interest" in pediatric drug development.

    May 31, 2012

  • PCORI’s Research Agenda is Broad, Cost-Neutral

    May 29 | eCliniqua | The role of cost and patients in comparative effectiveness research (CER) were among the themes of a Post-Approval Summit held earlier this month at Harvard Medical School*. So, too, was the agenda and funding priorities of the latest actor in the CER arena: the independent, multi-stakeholder Patient-Centered Outcomes Research Institute (PCORI). 

    May 29, 2012

  • Building Electronic Clinical Trials is Grueling and Slow—Recent Survey

    May 21 | eCliniqua | The tedious process of building an electronic clinical trial is a stubborn bottleneck requiring too much time and too many resources. Those are the topline results of a 2011 survey conducted at two annual meetings—the Drug Information Association (DIA) and the Society for Clinical Data Management (SCDM). Cmed Technology, a UK-based provider of eClinical solutions developed and administered the survey, which resulted in 87 respondents from 55 companies. 

    May 21, 2012

  • Lung Cancer Trial Combines Blood Test and Imaging

    May 7 | News Brief | National Jewish Health is seeking to refine and improve lung-cancer screening by combining a blood test with CT imaging to detect disease earlier and more effectively. The trial combines a CT chest scan and the EarlyCDT-Lung blood test to screen for cancer.

    May 7, 2012

  • Quanticate Opens Bangalore Office

    May 4 | eCliniqua | Quanticate is expanding its contract research capabilities for clinical trials in India with the announcement of a new office in Bangalore. The new office will take further advantage of growing clinical trials opportunities in India. 

    May 3, 2012