News from the World of Clinical Research

Recent News

    How Amazon Could Disrupt The CRO Model

    By ICR Secretariat / 11/19/2017 2:36:03 PM

    Kenneth Wu:

    'After my last Clinical Leader article, "How Amazon Could Improve Patient Experience", a friend of mine recommended the book The Everything Store: Jeff Bezos and the Age of Amazon, by Bra…

    International Clinical Researcher of the Year

    By ICR Secretariat / 11/19/2017 2:32:23 PM

    Designed to challenge, recognise and reward the talent and passion of industry and academic researchers, the PharmaTimes International Clinical Researcher of the Year is a rigorous, real world competi…

    Joint Statement on the Application of Good Clinical Practice to Training for Researchers

    By ICR Secretariat / 11/2/2017 9:31:22 AM

    This joint statement advocates a proportionate approach to the application of GCP training to researchers.
    Good Clinical Practice (GCP) is an international ethical and scientific quality standard for d…


    ICR General Administration Internship

    By ICR Secretariat / 11/1/2017 4:46:05 PM

    The ICR is looking for 2 graduates to join us as an part-time intern for 3-6 months from November. We launched our internship scheme in the summer of 2015 and have had 13 interns join our scheme.

    Thi…

    EudraVigilance cutover period 8-21 November SUSARs submission

    By ICR Secretariat / 10/27/2017 3:33:20 PM

    During the EudraVigilance cutover period, 8 - 21 November it will not be possible to submit SUSARs via EudraVigilance, EVWEB, EVCTM. Please click the link above, or click here for details of how to su…

    Ransomware Infection Warning- 'Bad Rabbit'

    By ICR Secretariat / 10/27/2017 3:26:44 PM

    There is a new ransomeware infection called 'Bad Rabbit'. Do not download, or click on a link for anything claiming to be an Adobe Flash Player update. Please note, updates are never sent out by email…


    ICR Ethics & GCP Forum

    By ICR Secretariat / 10/12/2017 4:37:27 PM

    The ICR Ethics and GCP Forum is now fully booked! If you would like to register on the wait list, please contact the ICR office either by phone [016285 501700] or by email [office@icr-global.org]

    Kristen McLeod takes on the leadership of the Office for Life Sciences

    By ICR Secretariat / 10/1/2017 7:24:14 PM

    The Department of Health and the Department for Business, Energy and Industrial Strategy are delighted to announce that Kristen McLeod will take up the post of Director of the Office for Life Sciences…


    New EU GMP Legislation published

    By ICR Secretariat / 9/28/2017 4:55:20 PM

    The European Commission has published new GMP legislation in the Official Journal of the EU. Directive 2017/1572 covers GMP for marketed products and delegated Regulation 2017/1569 covers GMP and insp…

    EMA staff favour move to Amsterdam

    By ICR Secretariat / 9/28/2017 4:21:27 PM

    The EMA has told the EU Commission that Amsterdam is the preferred choice among its staff for its new headquarters, according to reports.

    On Tuesday the body warned of a ‘public health crisis’ if it …

    MHRA- Upcoming GCP stakeholder engagement meeting

    By ICR Secretariat / 9/25/2017 5:19:02 PM

    The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.…


    Intercept shares plummet on FDA warning

    By ICR Secretariat / 9/25/2017 5:03:58 PM

    'The Food and Drug Administration has followed up Intercept Pharmaceuticals' "Dear Health Care Provider" letter with a drug safety communication concerning Intercept's Ocaliva, used to treat primary b…

    MHRA Survey

    By ICR Secretariat / 9/19/2017 10:47:44 AM

    The Medicines and Healthcare products Regulatory Agency is conducting a survey to better understand how it can support its customers.

    'As part of our continued commitment to deliver a high-quality se…

    EMA Annual Report of the GCP IWG 2016

    By ICR Secretariat / 9/6/2017 1:58:37 PM

    The EMA has released the 2016 Annual Report of the Good Clinical Practice Inspectors Working Group.

    The GCP IWG focuses on harmonisation and coordination of GCP related activities at EU level. 

    The…


    GCP inspection metrics for 2015 to 2016 published

    By ICR Secretariat / 7/24/2017 11:47:55 AM

    Last week the MHRA published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.


    During the metrics period a total of 102 GCP Inspections were undertaken by the MHRA GCP Inspectorate…

    Statistical analysis outlines level of data fabrication in some clinical trials

    By ICR Secretariat / 6/22/2017 3:22:20 PM

    A statistical analysis of just over 5,000 randomised, controlled trials published in anaesthetic and general medical journals has found suspicious statistical patterns in some, raising concerns over t…

    Action needed to prevent confusion over medicines

    By ICR Secretariat / 6/22/2017 3:15:40 PM

    Only about a third (37%) of the public trust evidence from medical research, compared to approximately two-thirds (65%) who trust the experiences of their friends and family*, according to a report la…


    HRA Update - Single form to REC and R&D Submissions from next week

    By ICR Secretariat / 6/22/2017 10:41:39 AM

    From the evening of 28 June 2017, a combined IRAS form that merges the Research Ethics Committee (REC) and R&D forms will be used across the UK. Already in place for projects where the lead NHS R&…

    FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

    By ICR Secretariat / 6/20/2017 1:39:22 PM

    The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments a…

    Governments Must Commit Funding for Data Sharing to Flourish

    By ICR Secretariat / 6/20/2017 1:17:59 PM

    Data sharing is widely agreed to be beneficial for both scientists and the general public, but hosting data is expensive, and government agencies rarely have the funds to build and support such platfo…


    Merck pauses cancer studies due to patient deaths

    By ICR Secretariat / 6/20/2017 1:06:23 PM

    Mercks has paused enrollment in two studies for their immunotherapy drug, Keytruda after an external Data Monitoring Committee reccomendation. The Committee has recommended the move to gain more infor…