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Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites


Date: December 13, 2016 (60 minutes)

Featured Speakers:

This webinar will focus on how Investigator Sites are preparing for ICH-GCP E6(R2) and its impact on remote monitoring.

For the first time in two decades, significant updates to the international guideline for clinical trials will soon be released. Slated for November 2016, the revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonisation (ICH) has major implication for stakeholders and reflects the industry’s growing emphasis on risk-based quality management supported by expanded use of innovative technologies.

This guideline, known as ICH-GCP E6(R2), highlights the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for increased efficiency in quality management. Specifically, describing quality management as multi-faceted, with emphasis on re-imagining protocol design to minimize complexity, unnecessary procedures and related data collection key to better decision making.

Join this webinar to find out how this applies at investigator sites and hear directly from Dan Sfera about how sites are already today using Intralinks in making these process changes possible along with why it’s critical for sites to embrace digital transformation to improve their efficiencies and facilitate remote monitoring.

From starting as a study coordinator in 2005, Dan now owns 8 investigator sites spread across North America, a recently founded CRA academy and run for over 6 years ‘The Clinical Trial Guru’ blog demystifying clinical trials (in his trademark hoodie) for research professionals and participants alike, but especially educating thinking about venturing into this industry.

Keywords: Remote Monitoring , E6(R2)


    Andrew Mitchell

    Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks

    Andrew Mitchell has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions. In addition to Intralinks, Andrew’s career includes positions with Covance, Relsys, Medidata and BioPharm Systems (an Oracle Gold implementation partner). With a focus on Software as a Service, Andrew brings his deep subject matter expertise to bear to ensure the delivery of real benefits and enhanced compliance, anchored by a strong belief in providing solutions that simplify and improve the user experience.

    Intralinks provides a highly secure platform that helps pharmaceutical, biotech, medical device companies and clinical research organizations (CROs) to streamline complex and time-sensitive processes such as eISF/eTMF integration, SUSAR report distribution and study start-up with a complete audit trail. Intralinks´ clients automate distribution and collection of sensitive information, centrally organize content while easily managing and monitoring access - making it easier to provide the right information to Investigators, Institutional Review Boards (IRBs)/Ethics Committees ( ECs), regulatory agencies and patients.

    Dan Sfera

    Dan Sfera, The Clinical Trials Guru

    Dan Sfera has owned and operated clinical research sites since 2005. In 2010 Dan decided to get into blogging about clinical research in order to generate more business for his clinic as well as to attract potential study participants to his existing studies. Soon he discovered that the majority of the audience members were actually other clinical research professionals who were taking to the internet to try and learn more about the industry. His blog became a place to demystify clinical trials and help other research companies accomplish their business objectives by creating practical solutions to their real world problems.


    Clinical Trials professionals, including:

    • Clinical Site Selection/Management Personnel
    • Clinical Site Coordinators (CRCs)
    • Clinical Research Associates/Monitors (CRAs)
    • Clinical Trial Managers (CTMs)
    • Data Managers
    • Investigators
    • Clinical Operations & Project Management
    • Compliance & Regulatory Affairs


    PharmaCompass is the one-stop, pharmaceutical information platform developed for professionals to make your strategic business decisions. It's your free-access, integrated global database with detailed regulatory information on products and companies. The PharmaCompass’ team directly connects buyers to the right contacts at the suppliers without getting involved in commercial transactions.

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    Intralinks is changing how we think about secure collaboration by reinventing the way companies do business externally.

    Access and share secure documents anytime, anywhere, and from any device. Intralinks gives you the freedom to work beyond boundaries — and the security to do so with absolute confidence.

    Discover how we’re helping sponsors and CRO’s revolutionize their clinical trial processes by providing HIPAA-complaint virtual workspaces to investigator sites for them to control and which enable remote monitoring - even of non-redacted patient information.

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