• Clinical Conductor CTMS and OpenClinica EDC Form First of its Kind Partnership(2)

    Oct 3, 2014, 00:00 by Michael Croft
    ROCHESTER, NY, UNITED STATES - Oct 3, 2014 - Clinical Conductor CTMS, the leading clinical trial management system, and OpenClinica, one of the world's most widely adopted electronic data capture (EDC) software platforms, are pleased to announce the formation of a strategic partnership to deliver a seamless EDC-CTMS integration to drive productivity in clinical research
    Full story
  • September Clinical News and Product Briefs

    Oct 2, 2014, 08:10 by Michael Croft
    Clinical Informatics News | News and product releases from around the industry, including the ATHENA study of Alport syndrome, and a customizable patient portal for results from genome sequencing.
    Full story
  • WIRB-Copernicus Group Appoints Dr. Lindsay McNair to the Role of Chief Medical Officer

    Oct 2, 2014, 00:00 by Michael Croft
    PRINCETON, NJ - Oct 2, 2014 - WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services and software to support clinical research, announced today that Lindsay McNair M
    Full story
  • Personal Attention for Regular Hospital Visitors

    Oct 1, 2014, 08:35 by Michael Croft
    Kaiser Health News | The Camden Coalition of Healthcare Providers is conducting a long-term clinical trial to test whether giving personal "coaching" attention to the heaviest users of hospital systems will reduce readmissions and improve patient wellbeing.
    Full story
  • Clinical Conductor CTMS and OpenClinica EDC Form First of its Kind Partnership

    Oct 1, 2014, 00:00 by Michael Croft
    ROCHESTER, NY, UNITED STATES - Oct 1, 2014 - Clinical Conductor CTMS, the leading clinical trial management system, and OpenClinica, one of the world's most widely adopted electronic data capture (EDC) software platforms, are pleased to announce the formation of a strategic partnership to deliver a seamless EDC-CTMS integration to drive productivity in clinical research
    Full story
  • Rho Highlights Risk-Based Monitoring and History of Success at 6th Annual OCT New England Conference

    Sep 30, 2014, 00:00 by Michael Croft
    CHAPEL HILL, NC, UNITED STATES - Sep 30, 2014 -   WHAT:  Rho, a full-service contract research organization (CRO), is showcasing its 30-year history of success in drug development strategies and services, including risk-based monitoring (RBM) strategies, at the Outsourcing in Clinical Trials (OCT) New England Conference taking place October 7-8 in Boston, Massachusetts
    Full story
  • Big Results for Perjeta are Big Boost for Personalized Medicine

    Sep 29, 2014, 12:00 by Michael Croft
    Clinical Informatics News Brief | The CLEOPATRA study, which began recruitment in 2008 for an 800-patient clinical trial of the antibody therapy Perjeta in breast cancer, has just released its results, showing an incredible survival gain of nearly 16 months.
    Full story
  • Health Policy Advocates Protest Auction of .health Internet Domain

    Sep 26, 2014, 11:05 by Michael Croft
    Clinical Informatics News | The Internet Corporation for Assigned Names and Numbers, the Los Angeles-based nonprofit that sets global policy for Internet domain names, plans to shortly auction off the rights to sell health-related top-level domain names, including .health, a scheme that is drawing protests from medical and public policy organizations.
    Full story
  • FDA's Sentinel Project Advances from Pilot Stage

    Sep 24, 2014, 10:55 by Michael Croft
    Nature News | The Sentinel Initiative, launched in 2008, aims to collect adverse event reports from electronic health records and insurance claims databases, giving the FDA an additional tool to monitor the safety characteristics of drugs and medical devices after they reach the market.
    Full story
  • Outstanding Dotmatics UGM Draws Record Attendance from across the Globe

    Sep 24, 2014, 00:00 by Michael Croft
    BISHOP'S STORTFORD, UK - Sep 24, 2014 - ~~Dotmatics, a leading provider of scientific informatics solutions and services, announced today that this year’s European User Group Meeting (EUGM) held at Down Hall Country House Hotel, Hertfordshire was the largest and most successful to date
    Full story
  • ePharmaSolutions Joins the WIRB-Copernicus Group

    Sep 24, 2014, 00:00 by Michael Croft
    PRINCETON, NJ - Sep 24, 2014 - WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for clinical research, announced today that ePharmaSolutions (ePS) has joined its group of companies
    Full story
  • Risk to Patients Balanced Against Risk to Labs as FDA Moves on Lab Developed Tests

    Sep 23, 2014, 11:45 by Michael Croft
    Clinical Informatics News | On September 29, the FDA is set to issue a draft guidance that will, for the first time, subject tests developed and used in single laboratories to FDA oversight. While the agency worries about the risk to patients from unapproved tests, hospital and academic labs fear that the costs of regulation will shut down their most innovative procedures.
    Full story
  • Western IRB (WIRB) Awarded AAHRPP Reaccreditation

    Sep 22, 2014, 00:00 by Michael Croft
    PRINCETON, NJ - Sep 22, 2014 - WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for clinical research, announced today that its Western Institutional Review Board® (WIRB) has been reaccredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which endeavors to improve safeguards for clinical research participants
    Full story
  • ACRES to Produce Global Accreditation Standards for Trial Sites

    Sep 18, 2014, 09:40 by Michael Croft
    Clinical Informatics News Brief | The Alliance for Clinical Research Excellence and Safety (ACRES), an international group aiming to unite clinical trial sites around the world under common standards and data networks, has announced that it will begin drafting global guidelines for the accreditation of research sites.
    Full story
  • Multiple Myeloma Clinical Trials Kick Into High Gear

    Sep 16, 2014, 08:55 by Michael Croft
    Clinical Informatics News | A year after launching its online research gateways to connect multiple myeloma patients and researchers across the country, the Multiple Myeloma Research Foundation is witnessing a boom in fast-track drug approvals and late stage trials for the disease.
    Full story
  • What Weight Should Oncologists Give to Retrospective Trials of Common Drugs?

    Sep 15, 2014, 11:40 by Michael Croft
    Oncology Live | Maurie Markman, National Director for Medical Oncology at Cancer Treatment Centers of America and editor-in-chief of Oncology Live, writes a thoughtful editorial on the growing number of retrospective studies showing a benefit for common non-cancer drugs in cancer cases.
    Full story
  • Sanger Institute to Implement Real-Time Sequencing in Outbreaks

    Sep 12, 2014, 11:00 by Michael Croft
    The Guardian | After retrospective studies of hospital-centered outbreaks, in which whole-genome sequencing was used to track bacteria with multiple antibiotic resistance, the U.K.'s Wellcome Trust Sanger Institute is planning to recreate this system for use during the course of an outbreak.
    Full story
  • New England Independent Review Board Joins the WIRB-Copernicus Group

    Sep 10, 2014, 00:00 by Michael Croft
    PRINCETON, NJ - Sep 10, 2014 - WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for clinical research, announced today that New England Independent Review Board (IRB) has joined the group of companies
    Full story
  • European Pharma, Regulators to Produce Adverse Events App

    Sep 9, 2014, 09:40 by Michael Croft
    In-Pharma Technologist | A team led by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) and Swiss drug developer Novartis is collaborating on an app that could be used by patients and providers to step up reporting of adverse drug events.
    Full story
  • DoD Contract Could Be Major Force in Shaping EHR Interoperability

    Sep 8, 2014, 12:35 by Michael Croft
    Clinical Informatics News | The Department of Defense is planning new measures to overhaul its electronic health records system, which covers the medical histories of roughly ten million Americans, and the department plans to make interoperability a top priority.
    Full story