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DAILY NEWS

Big Results for Perjeta are Big Boost for Personalized Medicine
| 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. more

Health Policy Advocates Protest Auction of .health Internet Domain
| 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. more

FDA's Sentinel Project Advances from Pilot Stage
| 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. more

Risk to Patients Balanced Against Risk to Labs as FDA Moves on Lab Developed Tests
| Clinical Informatics News | On September 29, the FDA is set to issue a draft guidance that will, for the first time, subject tests developed and used in single laboratories to FDA oversight.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. more

ACRES to Produce Global Accreditation Standards for Trial Sites
| 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. more

Multiple Myeloma Clinical Trials Kick Into High Gear
| 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. more

What Weight Should Oncologists Give to Retrospective Trials of Common Drugs?
| 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. more

Sanger Institute to Implement Real-Time Sequencing in Outbreaks
| 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. more


PRESS RELEASES
ePharmaSolutions Joins the WIRB-Copernicus Group
| 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 more

Outstanding Dotmatics UGM Draws Record Attendance from across the Globe
| 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 more

Western IRB (WIRB) Awarded AAHRPP Reaccreditation
| 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 more

New England Independent Review Board Joins the WIRB-Copernicus Group
| 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 more

Rho Recognized for Exemplary Workplace Practices
| CHAPEL HILL, NC, UNITED STATES - Sep 8, 2014 - Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, has again been honored with the 2014 When Work Works Award more

David Borasky Has Been Appointed Vice President of Quality Management for the Copernicus Group Independent Review Board
| PRINCETON, NJ - Aug 26, 2014 - WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services for clinical research, announced today that it has appointed David Borasky as vice president of quality management for the Copernicus Group Independent Review Board more

Vortex to accelerate anti-infective research at the Institute for Molecular Bioscience at the University of Queensland, Australia
| BISHOP'S STORTFORD, UK - Aug 20, 2014 - ~~Dotmatics, a leading provider of scientific informatics solutions and services, announced today that Prof more

Miltenyi Biotec acquires gene therapy assets from Lentigen Corporation
| BERGISCH GLADBACH, GERMANY - Aug 15, 2014 - Miltenyi Biotec announced today that it has acquired the lentiviral vector manufacturing business and related assets from US company Lentigen Corporation, a global leader in lentiviral technology for cell and gene therapy applications more



 

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