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November  5, 2009
The Journey Toward Paperless Clinical Trials
Speaker for this event:
  • Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting  Learn More
  • Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks  Learn More
  • The Journey Toward Paperless Clinical Trials

    Pharma companies are seeking to bolster pipelines and cut costs more than ever before in preparation for looming patent expirations of blockbuster drugs. In this environment global collaborations are increasing while budgets are shrinking, and as a result Internet-based communication has taken a prominent position in clinical development.

    In contrast to the rapid changes in the structure of development teams and the advancements in web-based communications tools, the progress toward completely paperless clinical trials has been notably slow.  Are we about to turn the corner and see new momentum? In over two decades since the first remote data entry systems were introduced, interfaces and speed of computer-based systems have improved greatly, yet the challenges of managing the paper distribution, collection and management of clinical regulatory documents in clinical trials persists. Join us for a live webcast as we discuss paperless clinical trials, covering the initiatives, the progress and what we have learned along the way.

    Discussion will include:

    • The push for paperless continues: A look at the latest trends and initiatives
    • Clinical studies end-to-end: Which parts of the process are farthest along and which have the highest hurdles
    • Who benefits? Views on the benefits and burdens of transitioning to paperless for sites, sponsors, regulators and others
    • Where from here? Practical next steps towards the paperless trial.

    EVPs, VPs, Directors, Department Heads, Project Managers of:

    • Clinical Trials
    • Clinical R&D
    • Clinical Operations
    • Clinical Recruitment Services
    • Regulatory Affairs
    • Medical Affairs
    • Biometrics & Statistics
    • Information Technology
    • Data Management
    • Safety
    • Outsourcing Management

    For pharmaceutical and biotech companies within North America and Europe.



    Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting 

    Gail M. Farfel, Ph.D. is a consultant to pharmaceutical and allied industry companies, advising clients with all aspects of pharmaceutical development and registration: clinical development planning and regulatory strategy, protocol design and study start up, clinical operations, Advisory Boards and FDA Advisory Committees. She has 18 years experience in US and global pharmaceutical development and marketing, including 11 years at Pfizer and 2 yrs as VP, Therapeutic Head, Neuroscience at Novartis. Dr. Farfel is familiar with all aspects of clinical trial design and start-up, having started as a Project Clinician at Pfizer, and worked on teams conducting research both in-house and using a CRO model. She has used and helped design remote data entry systems, web-based clinical study interfaces and document sharing workspaces since the early 1990's, and was a member of PhRMA's Clinical Trials Working Group.

    Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks 

    Alison Shurell is vice president of Life Sciences Product Marketing. She is responsible for building on IntraLinks position as the leading software as a service solution for critical information exchange in the Life Sciences industry. In this role, she works closely with industry leaders in pharmaceutical, biopharma and medical device companies, as well as investigative sites, IRBs/ECs and other members of the Life Sciences community to understand market trends, problems industry drivers to impact product strategy and direction at IntraLinks. Shurell’s background includes more than 15 years of experience in corporate marketing roles in the B2B software and financial services markets. She holds an undergraduate degree from Miami University and an MBA from Baldwin-Wallace College.


    Since 1997, more than 750,000 users representing over 90,000 organizations worldwide have used IntraLinks On-Demand Workspaces™ to safeguard documents, improve communication and collaborate on thousands of projects and deals.


    Life sciences professionals use IntraLinks On-Demand Workspaces™ to expedite processes, streamline information sharing and which give them a competitive advantage.

    More than 15,000 and growing registered investigative sites worldwide use IntraLinks On-Demand Workspaces to receive and manage clinical trial and safety document information.


    Our On-Demand Workspaces are a true turn-key solution, requiring no additional hardware or software, no expensive training programs and no new demands on internal IT resources.


    HealthEconomics.Com (http://www.healtheconomics.com/) is the premier website for health economics and outcomes research resources as well as jobs.  A newsletter is published every two weeks which includes current news, conferences, educational resources, and hot web resources.  The HealthEconomics.Com website contains links to Associations, Consulting Companies, Conferences, Databases, Education, Employment, Government, Humor, Journals, Libraries, News, Pharma/Biotech companies, and Questionnaires/Performance Assessment.  Scientific forums provide an opportunity for idea exchange.  

    "http://www.pharmcast.com/ is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals.  http://www.pharmcast.com/ brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors.  It was created and is maintained by pharmaceutical and biotechnology professionals.  Visit http://www.pharmcast.com/ and discover for yourself why it is so popular among professionals."

    European Pharmaceutical Manufacturer (EPM) magazine, published by Rapid News Communications Group, is the pharmaceutical supply chain for ingredients, equipment, contract services and more. Now in its ninth year of publication, it is the only tabloid-style publication in the field of pharmaceutical manufacture in Europe. For fresh, up-to-date news, visit the EPM website, http://www.pharm-europe.com/.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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