• 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

  • Novel IT Platform Helps Novartis Gain Control of Clinical Imaging Data

    Nov 16 | eCliniqua | Researchers at Novartis in Basel have developed a powerful new electronic data capture (EDC) hub for clinical data that has allowed its investigators to control data across multiple trials as never before, according to David Tuch, head of clinical imaging at the Novartis Institute for Biomedical Research, Switzerland. “This is a game changer for managing clinical trials at Novartis.”

    Nov 15, 2010

  • Most Trials Now Eligible for Design Simulation

    New simulation tool expands the range of eligible trials. By Deb Borfitz November 16, 2010 | The first upgrade to a one of a kind simulation tool co developed by Tessella and Berry Consultants significantly enlarges the proportion of clinical

    Nov 14, 2010

  • Databases Down Under

    Nov 15 | eCliniqua | BRISBANE—At TRX10, Translational Research Excellence, held last month in Brisbane, amid a wide-ranging program covering everything from stem cell models to commercializing academic innovations, translational approaches to cancer and central nervous system disease to trial design, discussion turned to repositories for genetic and clinical data. Researchers encouraged one another to share raw data, analyses, and clinical findings to further research and enable advances in medicine.

    Nov 14, 2010

  • The IP Picture for iPS Cells

    Nov 15 | eCliniqua | Expert Commentary | An exciting recent advance in medicine has been the generation of induced pluripotent stem (iPS) cells which are derived from somatic cells, rather than embryos, through a process of “de-differentiation.” But the advance raises important intellectual property and patent questions.

    Nov 14, 2010

  • Covance Signs 10-Year Deal With Sanofi, Buys Sites

    Nov 11 | News Brief | Covance has closed its transactions with sanofi-aventis to become its R&D partner over the next 10 years and to purchase sanofi-aventis' Porcheville, France and Alnwick, United Kingdom sites.

    Nov 5, 2010