• Partnering with Pharma: A New CRO Approach

    Feb 2 | eCliniqua | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”

    Jan 26, 2011

  • The New Normal for Clinical Trials

    Jan 31 | eCliniqua | An assortment of emerging clinical trial technologies over the past decade are providing creative ways for pharmaceutical companies and clinical research organizations (CROs) to boost the quality, pace, and efficiency of their drug development programs. The promise is sporadically realized by companies that selectively and appropriately apply these tools and use timely and visible performance metrics as the basis for relationship-building with clinical investigators. Working recipes are not often diligently followed, however. Thus clinical trials performance, in the main, remains dreadful.

    Jan 26, 2011

  • Government to Fund Drug Research

    Jan 25 | New York Times | The government's new drug development center, the National Center for Advancing Translational Sciences, isn't intended to be comptetitive with the private sector, says NIH director Francis Collins. The center is slated to open in October and will be one of the 27 centers and institutes under the National Institutes of Health.

    Jan 24, 2011

  • Cetero Hires Former Schering-Plough Bioanalytical Director

    Jan 20 | News Brief | Cetero Research, an early-stage contract research organization, has appointed Roger Hayes as president, bioanalytical operations. For the past 10 years, Hayes has served as director of bioanalytical at Schering-Plough Research Institute. 

    Jan 19, 2011

  • Past Clinical Trials Not Cited

    Jan 18 | New York Times |  Johns Hopkins researchers have found that published papers on clinical trials rarely cite previous works on the same topic.

    Jan 18, 2011

  • Partnering with Pharma: A New CRO Approach

    Jan 18 | eCliniqua | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”

    Jan 18, 2011

  • Merck, Parexel Sign Generics Deal

    Jan 13 | Boston Business Journal | Parexel and Merck have signed a deal to help the pharma develop generic versions of biologics.

    Jan 12, 2011

  • Portal Partnering: Connecting Pharma and CROs

    Jan 10 | Comment |  The contract research market grew 13% in 2009, reaching $23.5 billion, according to the Contract Research Annual Review 2010 report. But as these partnerships with contract research organizations (CRO) become more common, it will become essential to establish collaborative communications with their partners and leverage workflows to help encourage communication and improve the efficiency of the working relationship. A partner portal, connecting the sponsor with the CRO, is an effective platform to achieve these goals.

    Jan 10, 2011

  • First Candidate from Nanoengineering Platform

    Jan 10 | News Brief | BIND Biosciences has started the Phase 1 trial for the first candidate from its broad proprietary Medicinal Nanoengineering platform.

    Jan 10, 2011

  • Drug Approvals Down in 2010

    Jan 5 | Wall Street Journal | The FDA approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

    Jan 4, 2011

  • DIA Launches Regulator Affairs Certificate Program

    Jan 5 | News Brief | DIA has announced a regulatory affairs certificate program to provide comprehensive training on current regulations and their practical application to the development and commercialization of pharmaceutical, biotechnology, medical device, and related health care products.

    Jan 4, 2011

  • EMRs Have Mixed Effects on Productivity

    Dec 27 | UC Davis | A UC Davis study has found that electronic medical records may not be the "silver bullet" of health care reform that some hoped. The study measured the impact of electronic medical record-keeping on doctors' productivity.

    Dec 20, 2010

  • Health-IT Trends for 2011

    Dec 22 | Healthcare IT News | PwC has released six healthcare trends for 2011 based on a survey of 1,000 Americans including record spending on health-IT, big changes in benefit plan design and pricing, and further merger and acquisition activity.

    Dec 20, 2010

  • Evado to Launch Chinese Version of Clinical Trials Software

    Dec 19 | News Brief | Evado has entered a partnership with Taiwan’s clinical research organization, Fuga Biotechnology which will have exclusive distribution rights in Taiwan. Evado said it would develop a Chinese version of the Evado clinical trials software system with Fuga in 2011.

     

    Dec 20, 2010

  • TechTeam Global Acquired by Stefanini

    Dec 17 | News Brief | TechTeam Global has been acquired by Stefanini IT Solutions Group, resulting in a merger of the two companies to form a new subsidiary, Stefanini TechTeam.

    Dec 20, 2010

  • Reducing the Burden of Clinical Safety Reporting

    Dec 21 | Commentary | Serious adverse event (SAE) reporting during clinical trials is a time-consuming, costly, and often manual task for investigational sites, and adds significant burden to research sponsors’ data management teams. EDC prevalence at investigational sites provides opportunity to automate and simplify SAE reporting.

    Dec 20, 2010

  • Charles River Plans Closure of Two Facilities

    Dec 16 | Mass High Tech | Charles River Laboratories plans seek "strategic alternatives" for two facilities: a Phase I research clinic in the U.S. and a pre-clinical research facility in China.

    Dec 15, 2010

  • Medtronic Announces Diabetes Decision Support

    Dec 15 | News Brief | Medtronic has announced the Food and Drug Administration (FDA) approval and the market launch of CareLink Pro 3.0 Therapy Management Software, the first software program to offer advanced decision support to health care professionals managing diabetes.

    Dec 14, 2010

  • Octagon, ScenPro Support FDA Data Conversion Project

    Nov 30 | News Brief | Octagon and ScenPro have partnered to support the FDA's large-scale legacy data conversation project. The project addresses legacy data that resides in numerous different formats at FDA that must be converted into standard structures.

     

    Nov 29, 2010

  • Taming the Beast

    Nov 15 | eCliniqua | Copernicus Group made a fairly weighty donation to a local North Carolina school last month: four boxes of paperclips and binder clips all formerly used to wrangle the “paper-moving beast” that was Copernicus’ clinical trial review process. The independent institutional review board (IRB) doesn’t need them anymore. They’ve gone completely paperless.

    Nov 15, 2010