• DIY Clinical Trials

    Apr 2 | Wall Street Journal Blog | DIY science is growing in popularity, especially as sequencing costs fall and genomics becomes more accessible. So it's not surprising that the DIY clinical trial is gaining ground as well. An investment advisor in Silicon Valley launched her own clinical trial on the type of vitamin B she, and others with her genotype, should take.

    Apr 2, 2012

  • Oracle Acquires ClearTrial Clinical Software

    Apr 2 | PC World | Oracle acquired ClearTrial late last week for an undisclosed amount in a deal expected to close in the first half of the year. Oracle hopes to combine ClearTrial's cloud-based clinical trials software offerings with its existing portfolio including tools that came with the 2010 Phase Forward acquisition. 

    Apr 2, 2012

  • Lessons Learned: Sites Leveraging CTMS to Increase Efficiencies, Boost Bottom Line

    Mar 23 | Guest Commentary | It’s no secret that the clinical trial environment is changing, with the constant need to increase efficiencies and overall performance while reducing costs. However, it’s worth noting that there are sites successfully implementing strategies to meet these demands through the implementation of clinical trial management systems. The Lynn Health Science Institute (LHSI) is one such site. As an emerging leader bringing new drugs to market through its clinical trials program, LHSI has completed over 300 clinical trials, working with over 200 pharmaceutical companies and CROs.   

    Mar 22, 2012

  • GNS Healthcare Aids Search for Fresh Leads on CHF Readmissions

    Mar 19 | eCliniqua | Hypotheses culled from real-world outcomes data will be getting large-scale testing by Harvard-affiliated Brigham and Women’s Hospital. The advanced analytics of GNS Healthcare are being applied to de-identified data from electronic health records (EHRs), pharmacy data, and administrative claims information to determine what factors contribute to adverse drug reactions and hospital readmissions in patients with congestive heart failure (CHF), says David Bates, director of the hospital’s Center for Patient Safety Research and Practice. 

    Mar 16, 2012

  • Clinical Reference Laboratory Affirms CRO Position in Asia

    Mar 8 | Manufacturing Chemist | Clinical Reference Laboratory (CRL), a US-based provider of central laboratory services for clinical trials with a European operation in Cambridge, UK, has fully integrated its long-standing laboratory partner Phoenix Pharma Central Services in Singapore. 

    Mar 18, 2012

  • 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