• Major Milestone in Development of New CDISC Device Standard

    Mar 6 | News Brief | The Clinical Data Interchange Standards Consortium (CDISC) announced a public review and comment period for the new CDISC Device Standards and encouragement for device companies to be involved in CDISC activities. This marks the first development by CDISC of standards for device trials. 

    Mar 18, 2012

  • February New Products

    Feb 27 | Bio-IT World | New products for February including new products from DATATRAK for clinical trial randomization and supply management, and DecisionView's latest version of StudyOptimizer for pateint enrollment planning, tracking, and forecasting.

    Mar 18, 2012

  • February News Briefs

    Feb 23 | Bio-IT World | February news briefs from around the Bio-IT industry including CDISC's expansion in Europe with the Innovative Medicine Initiative and the European Organisation for Reserch and Treatment of Cancer.

    Mar 18, 2012

  • Budget Woes Stall Clinical Trials and Stymie Sites

    Feb 20 | eCliniqua | 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. 

     

    Feb 19, 2012

  • FDA Releases Social Media Guidelines

    Jan 9 | Scientist | 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.

    Jan 8, 2012

  • Expect Measurable ROI of Innovation in 2012

    Jan 5 | eCliniqua | Guest Commentary | 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. 

    Jan 5, 2012

  • CDISC and IMI Sign Standards Agreement

    Dec 19 | eCliniqua | The Innovative Medicines Initiative Joint Undertaking (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients.

    Dec 18, 2011

  • Seven Elements of Clinical Collaboration Integration

    Dec 19 | eCliniqua | Guest Commentary | Running a clinical trial in the U.S. is expensive, and document management is one of the most time consuming and costly pieces of the puzzle. The amount of documents, work items, notifications, and other elements of collaboration is growing, resulting in increased management costs and the need to disseminate important information across the organization quickly and efficiently. 

    Dec 18, 2011

  • Raiders of the Lost Protocol—Understanding Past Performance to Predict Future Success

    Dec 19 | eCliniqua | Guest Commentary | Protocol complexity continues to increase as studies target ever more narrow patient populations and organizations embrace adaptive designs, in order to do more with less. By thinking of themselves as data archaeologists, today’s protocol authors can leverage the information from previous studies, as well as their operational outcomes, to ensure better protocol design and guarantee operational feasibility. 

    Dec 18, 2011

  • Web Site Visualizes Adverse Events

    Dec 5 | News Brief | Nhumi Technologies has unveiled its new web site providing direct access to the safety information of U.S. marketed drugs. The web site presents adverse events reported to the U.S. FDA since 2004. It identifies the most relevant safety information and depicts it on a virtual model of the human anatomy showing body parts that are most adversely affected by a drug. 

    Dec 5, 2011

  • An Inside Perspective on PAREXEL

    Nov 22 | Bio-IT World | Mark Goldberg, PAREXEL’s chief operating officer, recently sat down with Bio•IT World chief editor Kevin Davies to discuss the importance of convergence in Perceptive’s suite of eClinical offerings, and to share his insights on the future opportunities, trends, and challenges facing the industry. 

     

    Nov 21, 2011

  • PerkinElmer Targets Holistic Data Solutions

    Nov 21 | Bio-IT World | With its recent acquisitions of CambridgeSoft and Geospiza to name but two, PerkinElmer is signaling a new strategy that highlights data analysis and software as much as its traditional strengths in hardware and chemical analysis. Dan Marshak sat down with Bio•IT World chief editor Kevin Davies to discuss PerkinElmer’s evolving strategy from both business and scientific perspectives. 

    Nov 20, 2011

  • New Survey Results Show Asia Pacific CRO Trends

    eCliniqua | Guest Commentary | A new survey of contract research trends in Asia Pacific shows mostly small-to-medium contracts in Phase III focused on oncology.   

     

    Nov 10, 2011

  • NuMedii’s New Way to ‘De-Risk’ Drug Repositioning Work

    eCliniqua | A newly minted biotechnology company is offering to match the molecular genomic activity of previously approved medicines to that of known diseases to help drug makers find new uses for therapies. “We have two published studies demonstrating [our technology platform] can be used that way, and a third pending publication,” says Gini Deshpande, founder of Menlo Park, CA-based NuMedii. 

     

    Oct 17, 2011

  • Lilly Designs Study to Increase Minority Participation

    By eCliniqua Staff September 26, 2011 | Eli Lilly announced the findings from a study designed to increase minority participation in clinical trials last week. The company recognized that racial and ethnic minorities are more likely to develop cancer and

    Sep 25, 2011

  • Inovio: A Rising Star in the World of Vaccines

    September 19, 2011 | In as few as five years, all of the major shortcomings of conventional vaccines will start to vanish as the first DNA-based vaccines hit the market. The vaccines will be remarkably safe and tolerable, easily modified, and cheap to produce in a manufacturing process akin to brewing beer. They’ll also have a long shelf life, maintaining their fidelity even in steamy tropical climates. The development process itself will better integrate scientific inquiry with trial design, so that subsequent vaccines improve with the regularity of an iPhone upgrade. 

     

    Sep 18, 2011

  • Facebook and Pharma – an Uneasy Alliance

    September 19, 2011 | On August 15, 2011, Facebook implemented a change in policy that redefines the ground rules for the pharmaceutical industry’s use of this popular social medium.  As of that date, pharma companies no longer have the privilege of disabling comment walls on their company-sponsored Facebook pages.  The inability of consumers to post or view comments had been a special accommodation from Facebook to the pharmaceutical industry, but no more.    

    Sep 18, 2011

  • Less than 1% of Cancer Patients Enrolled in Trials, Study Says

     

    August 29, 2011 | Less than 1% of cancer patients participate in a clinical trial, according to a study published in the September issue of the Annals of Surgery. 

     

    Aug 28, 2011

  • Trials at the Point-of-Care

    eCliniqua | A new type of clinical trial now undergoing testing at the Veterans Affairs (VA) Boston Healthcare System will likely be of interest to emerging accountable care organizations (ACOs) as well as the drug companies that court them. The new approach, most useful in comparative effectiveness research, overcomes the chief disadvantages of the two flanking options: an observational study involving non-experimental treatment decision making or a full-scale, randomized and placebo-controlled trial. 

     

    Aug 15, 2011

  • ClearTrials Releases Study Budgeting Survey Results

    By eCliniqua Staff August 4, 2011 | ClearTrial, maker of clinical trial operations software for planning and budgeting trials, released results of a survey earlier this week assessing how life sciences professionals forecast and budget for clinical trials. Almost half of the

    Aug 4, 2011